Manual Btl-08 Sd

V 1 0 0 I E 0 2 / 0 7 / 2 0 0 7

BTL-08

Spiro

Spiro Pro

Manulalul utilizatorului

BTL -08 Sp i r o M A N U A L U L U T I L I Z A T O R U L U I

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CUPRINS

1 CARACTERISTICI ALE APARATULUI.............................................................................................................. 4

2 PERFORMANTE ALE TESTULUI DE SPIROMETRIE....................................................................................... 5 2.1 Contraindicatii ................................................................................................................................................ 5 2.1.1 Absolute ................................................................................................................................................... 5 2.1.2 Relative .................................................................................................................................................... 5 2.2 Conditii care pot influenta considerabil rezultatele masuratorilor [1] .............................................................. 5 2.3 Secventa recomandata a testelor .................................................................................................................. 5 2.4 Performante ale testului de spirometrie de forta ............................................................................................ 6 2.4.1 Spirometrie de forta inspiro/expiro ........................................................................................................... 6 2.4.2 Expiratory forced spirometry .................................................................................................................... 8 2.5 Performance of relaxed spirometry test ....................................................................................................... 10 3 INSTRUCTIONS FOR USE............................................................................................................................... 12 3.1 Description of THE BTL- 08 Spiro................................................................................................................ 12 3.1.1 Keyboard and top panel of the device.................................................................................................... 12 3.1.2 Rear panel of the device ........................................................................................................................ 13 3.1.3 Pneumotachograph description.............................................................................................................. 14 3.2 Device assembly and putting into operation ................................................................................................ 14 3.3 Function summary of keyboard buttons....................................................................................................... 15 3.3.1 start ........................................................................................................................................................ 15 3.3.2 accept..................................................................................................................................................... 15 3.3.3 stop ........................................................................................................................................................ 15 3.3.4 print ........................................................................................................................................................ 15 3.3.5 analyse................................................................................................................................................... 15 3.3.6 forced ..................................................................................................................................................... 15 3.3.7 relaxed ................................................................................................................................................... 15 3.3.8 mvv......................................................................................................................................................... 16 3.3.9 profile ..................................................................................................................................................... 16 3.3.10 patient .................................................................................................................................................... 16 3.3.11 calibr....................................................................................................................................................... 16 3.3.12 child incentive......................................................................................................................................... 16 3.3.13 predict values ......................................................................................................................................... 16 3.3.14 contrast .................................................................................................................................................. 16 3.3.15 menu ...................................................................................................................................................... 16 3.3.16 up-arrow/down-arrow ............................................................................................................................. 16 3.3.17 esc ......................................................................................................................................................... 16 3.3.18 enter ....................................................................................................................................................... 17 3.3.19 on/off ...................................................................................................................................................... 17 3.3.20 paper feeder (FF – form feed) ................................................................................................................ 17 3.3.21 device reset............................................................................................................................................ 17 3.4 Printer and paper ......................................................................................................................................... 17 3.4.1 Paper sensitivity ..................................................................................................................................... 18 3.4.2 Roll paper with raster ............................................................................................................................. 18 3.4.3 USB printer setup................................................................................................................................... 18 3.4.3.1 resolution (dpi).................................................................................................................................. 19 3.4.3.2 printer test......................................................................................................................................... 19 3.4.4 Storing conditions of thermal-sensitive paper......................................................................................... 19 3.5 Storage battery ............................................................................................................................................ 19 3.6 Lithium battery ............................................................................................................................................. 20 4 COURSE OF EXAMINATION ........................................................................................................................... 21 4.1 Profile selection for collection of the spiro record......................................................................................... 21 4.2 Patient selection .......................................................................................................................................... 21 4.3 Pneumotachograph interface....................................................................................................................... 21 4.4 Examination procedure................................................................................................................................ 22 4.4.1 Examination in forced profile .................................................................................................................. 22 4.4.1.1 Inspiratory and expiratory forced spirometry (complete)................................................................... 23 4.4.1.2 Expiratory forced spirometry (expiratory).......................................................................................... 24 4.4.2 Examination in relaxed profile ................................................................................................................ 25 4.4.3 Examination in mvv profile ..................................................................................................................... 26 4.5 BTPS correction........................................................................................................................................... 27 4.5.1 ATP conversion into BTPS..................................................................................................................... 27 4.5.2 Measurement reliability and INTERPRETATION ................................................................................... 28


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4.5.3 Measurement results and their acceptance (FVC measurement) .......................................................... 28 5 SETUP MODE................................................................................................................................................... 30 5.1 Main menu................................................................................................................................................... 30 5.1.1 Records file ............................................................................................................................................ 30 5.1.2 Profile setup ........................................................................................................................................... 30 5.1.2.1 Forced, relaxed and mvv profile properties setup............................................................................. 31 5.1.3 Calibration.............................................................................................................................................. 31 5.1.4 Device setup .......................................................................................................................................... 32 5.1.4.1 Starting profile – selection of profile after start.................................................................................. 32 5.1.4.2 Line width ......................................................................................................................................... 32 5.1.4.3 Medical record of the patient–patient’s record setup ........................................................................ 32 5.1.4.4 Optional specifications of the patient ................................................................................................ 32 5.1.4.5 Paper and print setup ....................................................................................................................... 33 5.1.4.6 Module information ........................................................................................................................... 33 5.1.4.7 User setup ........................................................................................................................................ 33 5.1.4.7.1 Time and date ............................................................................................................................. 33 5.1.4.7.2 Display contrast .......................................................................................................................... 33 5.1.4.7.3 Language options ....................................................................................................................... 33 5.1.4.7.4 Touch screen calibration............................................................................................................. 33 5.1.4.7.5 Files correction............................................................................................................................ 33 5.1.4.7.6 Files system format..................................................................................................................... 33 5.1.4.7.7 Default setting without data loss ................................................................................................. 33 5.1.4.7.8 Device sleep mode interval ......................................................................................................... 33 5.1.4.7.9 Battery level indicator.................................................................................................................. 34 5.1.4.7.10 More… ........................................................................................................................................ 34 5.1.5 Patient selection..................................................................................................................................... 34 5.1.6 Doctor selection ..................................................................................................................................... 34 6 ACCESSORIES ................................................................................................................................................ 35

7 MAINTENACE AND DEVICE SAFETY ............................................................................................................ 36 7.1 Cleaning the device surface and its parts .................................................................................................... 36 7.1.1 Cleaning the touch screen...................................................................................................................... 36 7.1.2 Cleaning the paper sensors ................................................................................................................... 36 7.2 Hygiene, cleaning and disinfection of spirometric accessories in contact with the patient ........................... 37 7.2.1 Hygiene.................................................................................................................................................. 37 7.2.2 Cleaning ................................................................................................................................................. 38 7.2.3 Disinfection............................................................................................................................................. 38 7.2.4 Sterilization............................................................................................................................................. 39 7.3 Device safety ............................................................................................................................................... 39 7.4 Conditions of guarantee............................................................................................................................... 40 8 TECHNICAL SPECIFICATIONS....................................................................................................................... 41 8.1 Legend of the measurement parameters..................................................................................................... 43 8.1.1 Forced spirometry .................................................................................................................................. 43 8.1.2 Relaxed spirometry ................................................................................................................................ 45 8.1.3 Measuring of the maximum pulmonary ventilation volume..................................................................... 45 8.2 Predictive values.......................................................................................................................................... 46 8.3 Relevant standard specifications and recommendations............................................................................. 47 8.4 List of literature ............................................................................................................................................ 48 8.5 Manufacturer................................................................................................................................................ 49 8.6 Sale and service .......................................................................................................................................... 49 BTL CUSTOMER CARD.............................................................................................................................................. 50


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1 C A R A C T E R I S T I C I A L E A P A R A T U L U I

BTL-08 Spiro este un aparat modern pentru examinari spirometrice bazice si anumite masuratori aditionale (post medicale). Ofera analize detaliate, interpretare automata, si tiparire ale curbelor spirometriei. Exceleaza prin gama larga de caracteristici si mod de operare, facand-ul accesibil oricariu operator. Aparatul permite utilizatorului sa modifice usor valorile standard (valori predictive), sa aleaga pana la 15 parametrii pentru masuratoarea curenta, sa porneasca interpretarea automata pentru spirometria de forta sau sa defineasca o inregistrare pentru testele bronhoprovocative. BTL-08 Spiro este echipat cu un ecran grafic de inalta rezolutie ce ne permite sa vizualizam in timp real graficele flux-volum si volum-timp. Ecranul color exceleaza prin grafica de calitate si este ehipat cu butoane prin tehnica „touch screen”. BTL-08 Spiro este prevazut cu senzori pentru masurarea temperaturii ambientale, presiunii barometrice si a umiditatii relative. Din acest motiv, aparatul poate genera automat corectia automata a parametrilor in functie de conditiile BTPS. BTL-08 Spiro are integrata o imprimanta termica de 112 mm, ce permite tiparirea pe hartie termica format A5. Astfel toate graficele pot fi tiparite impreuna cu valorile masurate. BTL-08 Spiro are implementat inregistrarile pacientilor si un fisier pentru masuratori particulare, permitand inregistrarea si stocarea in memoria interna a 250 de inregistrari ale tuturor masuratorilor, si tiparirea lor ulterioara fie pe imprimanta termica fie, mult mai confortabil si mai economic, pe o imprimanta externa conectata prin portul USB. BTL-08 Spiro este prevazut cu acumulator intern. Masuratorile pot fi incepute imediat dupa ce aparatul a fost pornit si dupa ce s-au introdus datele personale ale pacientului, sau dupa ce s-a ales pacientul din baza de date. BTL-08 Spiro a fost dezvoltat dupa ultimile cunostinte si recomandari in conformitate cu referintele ATS / ERS 2005 si Standardele Europene pentru spirometrie, EN 13826.

Pneumotacograful pentru BTL-08 Spiro poate fi achizitionat separat si poate fi conectat ca accesoriu suplimentar la Electrocardiografele din gana BTL-08 EKG (BTL-08 ECG – type SD, MT Plus, LT, LT Plus, LC and LC Plus). Ultimile informatii despre produse pot fi gasite la adresa http://www.btl.ro.


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2 P E R F O R M A N T E A L E T E S T U L U I D E S P I R O M E T R I E

2 . 1 C O N T R A I N D I C A T I I

Aceasta lista cu contraindicatii ne spune cand producatorul nu recomanda a se realiza un anumit test.

2 . 1 . 1 A b s o l u t e

� Conditii postoperative dupa operatii toracale � Infarct miocardic in ultima luna � Episema – instabilitate a traiectului aerian � Hipersensibilitate pulmonara � Insuficienta respiratorie totala sau partiala – dificultati serioase in timpul schimbului de gaze

2 . 1 . 2 R e l a t i v e

� Conditii spontane dupa pneumothorax � Arterial – anevrisme venoase � Hipertensiune arteriala severa � Sarcina cu complicatii in luna a treia � Testul PRO in profilul MVV: Sindrom hiperventilare

2 . 2 C O N D I T I I C A R E P O T I N F L U E N T A C O N S I D E R A B I L R E Z U L T A T E L E M A S U R A T O R I L O R [ 1 ]

� Dureri pulmonare sau stomacale puternice � Dureri puternice faciale � Stress � Boli mentale � Fumat cu mai putin de o ora inaintea testului � Consumul de alcool cu mai putin de 4 ore inainte de examinare � Nivel ridicat de activitate cu cel putin 30 de minute inaintea examinarii � Mese abundente cu cel putin 2 ore inaintea examinarii � Imbracaminte mulata ce poate influenta respiratia maxima � Igiena senzorului de spirometrie – intotdeauna mentineti senzorul curat si uscat � Inserarea garniturii de silicon intre senzorul de spirometrie si pneumotacograf – in lipsa ei nu este posibila

masurarea oricerei curbe sau calibrarea senzorului!

2 . 3 S E C V E N T A R E C O M A N D A T A A T E S T E L O R

� Spirometrie de forta – FVC, PEF � Spirometrie la repaus – SVC, MVV � Inhalare de medicamente (daca este necesar) � Repetarea spirometriei de forta – examinare post-medicala


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2 . 4 P E R F O R M A N T E A L E T E S T U L U I D E S P I R O M E T R I E D E F O R T A

Aceasta este o examinare, cand ecranul va fiseaza un grafic cu bucla completa pentru inspiratie si respiratie - flux [F] / volum [V] - volum [V] / timp [t] (numai partea curbei corespunzatoare respiratiei) - si eventual, imagini de motivare pentru copii

Pasii ce trebuiesc urmati pentru a face o examinare:

PORNITI aparatul (on/off) – ALEGETI PROFILUL (FORCED - <<forta>>) – INTRODUCETI DATELE PACIENTULUI – PORNITI TESTUL (butonul start) – OPRIRE AUTOMATA.

Inaintea oricarei masuratori, verificati sau ajustati si setati acesti parametrii – acestia nu pot fi modificati in timpul inregistrarii: � Curatati si uscati perfect senzorul de spirometrie � Selectati profilul dorit � Selectati parametrii clinici (spiro parameters) � Selectati tipul de test (bronchodilator, bronchoconstrictor test) � Tipul dozajului � Selectate tip spirometrie de forta: completa; inspiro/expiro (complete) / expiro (expiratory) Examinarea va fi automat oprita dupa terminarea timpului (setat in profil); mai poate fi oprita in orice moment prin apasarea tastei stop. Daca masuratorile sunt acceptate, confirmati aceasta prin apasarea tastei accept. Pentru a tipari rezultatele, apasati print. Aparatul va porni imediat tiparirea pe hartia termica a rezultatelor obtinute in timpul masuratorilor. Masuratorile vor fi automat inregistrate in memoria aparatului! Evaluarea ambelor teste: Examinarea simpla se termina cu acceptarea celor 3 proceduri. Apoi, un tabel va fi afisat langa cele trei curbe din graficul Flux/Volum; tabelul include valorile masurate FEV1, FVC si PEF comparate cu valorile predictive, individual pentru fiecare procedura. In acelasi timp programul evidentiaza cea mai buna curba. Manual se poate alege oricare dintre curbe prin apasarea in tabel pe procedura corespunzatoare. In acelasi timp se face o reeditate a parametrilor afisati FEV1, FVC si PEF (ex. FVC+ inseamna ca acel FVC este recalculat, FVC- inseamna ca FVC nu se poate recalcula).

2 . 4 . 1 S p i r o m e t r i e d e f o r t a i n s p i r o / e x p i r o

� Porniti aparatul prin apasarea butonului on /off. � Alegeti profilul – menu – profile setup – forced si urmati instructiunile de pe ecranul aparatului. Examinarea

include o indeplinire a cel putin trei teste corecte (acceptate). � Introduceti numele si datele pacientului (data nasterii, sexul, greutatea, inaltimea si grupul etnic); acestea vor fi

necesare pentru a calcula valorile predictive; apasati butonul patient. � Verificati daca senzorul de spirometrie este curat. � Initializarea testului se face apasand butonul start. � Rugati pacientul sa respire calm, dar maxim, in pneumotacograf si imediat dupa aceasta sa inspire maxim si sa

expire maxim in forta – si in acelasi timp, incurajati pacientul prin ai spune „mai mult, mai mult” si „mai adanc” in faza de maxim a inspiro si expiro.

� Testul se termina automat dupa scurgerea timpului setat pentru profilul respectiv sau prin apasarea butonului

stop. � Imediat dupa terminarea primei proceduri, butonul accept va aparea in partea de jos a ecranului. Acceptati

aceste masuratori ca fiind corecte prin apasarea acestui buton si apoi continuati procedura prin apasarea butonului start.

� Vizualizarea rezultatelor primei proceduri se poate face prin apasarea butonului analyse (in partea de jos a

ecranului – dupa apasarea butonului accept); ne vor fi afsate rezultatele si curba inspiro/expiro pentru testul realizat.


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ATENTIE! Acesta este o terminare prematura a testului, si este imposibil sa mai continuam cu alte masuratori imediat dupa aceasta..

� BTL-08 Spiro va salva rezultatele dupa trei teste consecutive. Daca s-au efectuat trei teste corecte, atunci

rezultatele vor fi afisate pe ecran, si aparatul va alege automet cea mai buna curba in conformitate cu criteriul FEV1 + FVC in profilul forced.

Butoanele start si accept vor aparea la finalul fiecarei proceduri. In cazul unei proceduri nereusite, renuntati la datele culese prin apasarea butonului start; in cazul in care procedura este corecta, alegeti accept si continuati cu procedura urmatoare. Va recomandam sa aveti 3 masuratori corecte consecutive pentru a avea o comparatie corecta a rezultatelor.


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2 . 4 . 2 S p i r o m e t r i e d e f o r t a - E x p i r o

� Pornti aparatul prin apasarea butonului on/off. � Choose printing record profile – menu – profile setup – forced and follow the instructions on the display of the

device. The examination includes a completion of at least three correct (accepted) measurements (procedures). � Enter the patient's name and data (date of birth, sex, weight, height and race); this will be used for the calculation

of the predictive values and for the record analysis - press the patient button. � Check the cleanness of spirometric sensor and measuring wire-gauze. � The initiation of the signal collection will start by pressing the start button. � Ask the patient to maximally forcefully inspire (aside the spirometric module), immediately after that enclose the

mouthpiece of the spirometer in his lips and maximally narrowly breathe into the spirometric module. Encourage your patient during his maximal expiration by saying "more and more" and "even deeper". We recommend using a nose clip.

� The collection finishes automatically after a lapse of exact time in a certain profile (see examination in set profiles)

or by pressing the stop button. � Right after the first achieved procedure, the accept button will occur on the bottom line of the touch screen. You

will accept the measurements as correct by pressing this button and then continue with collection by pressing start.

� A view of the records from of the first procedure can be obtained by the analyse button (displayed on the bottom

line of the touch screen - after pressing the accept button), this view will show you the already measured results and values of the spirometric curve. WARNING! This is a premature termination of the examination, and it is impossible to continue further measuring after that.

� The BTL-08 Spiro will save the results after three consecutive collections. If there are three correct measurements

received (by the accept button) – then the results from the measurements will be displayed on the screen, and the device will accomplish an automatic selection of the best curves according to the criteria FEV1 + FVC in forced profile.

The buttons start and accept will appear at the end of each procedure. In the case of an unsuccessful measurement, carry out the collection again by pressing the start button, the results of the last measurement will be automatically discarded, if the test was accomplished correctly, choose accept and continue in measuring the next procedure. We recommend accomplishing 3 consecutive measurements for a correct comparison of the results.


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2 . 5 P E R F O R M A N C E O F R E L A X E D S P I R O M E T R Y T E S T

An examination in relaxed profile will test changing volume of lungs at the beginning of relaxed expiration – when the lungs are completely filled, to the end of expiration – when the lungs contain only a residual volume and conversely. Course of examination scheme:

SWITCH ON device on/off – CHOOSE PROFILE (RELAXED) – ENTER PATIENT'S DATA – START COLLECTION start button – AUTOMATIC FINISH.

Before starting the record, check or adjust and set these parameters – they cannot be changed during the record: � clean and absolutely dry the spirometric sensor and measuring net � clinical parameters (spiro parameters) � required profile Examination will be automatically finished after the time (set in profile) is up, it can be also stopped any time by the stop key. If the actual measuring is accepted, confirm it by pressing the accept button. Press the print key. The device will start printing the results of the gained values during measuring on thermal paper. Measurements are automatically stored in record files! � Switch the device on by pressing on/off. � Choose the printing record profile – menu – profile setup – relaxed and follow the instructions on the display of

the device. The examination includes the completion of at least three correct (accepted) measurements (procedures).

� Enter the patient's name and data (date of birth, sex, weight, height and race); this will be used for the calculation

of the predictive values and for the record analysis - press the patient button. � Ask your patient to grip the mouthpiece firmly in his lips and breathe calmly, tell him to perform a maximal deep

expiration without major effort until all the air is emptied from the lungs, and then slowly breathe until the maximum aspiration (so - called EVC procedure) and ask him again to perform everything conversely (so - called IVC procedure).

� Check the cleanness of spirometric sensor and measuring wire-gauze. � The initiation of the signal collection will start by pressing the start button. � The patient breathes composedly. When the curve crosses the vertical dashed line (6 seconds from the start of

measuring), ask the patient to perform the EVC procedure (deep expiration and then slow deep aspiration to the maximum) and after a short relaxed breathing (about 3 to 5 cycles) ask your patient to perform the IVC procedure (deep aspiration and then deep expiration until all air is out of lungs). The patient should accomplish both these procedures within 30 seconds – it is on the display marked by space between vertical dashed lines. The patient can continue with relaxed breathing, measuring is finished.

� The collection finishes automatically after a lapse of exact time in a certain profile (see examination in set profiles)

or by pressing the stop button. � Right after the first achieved procedure, the accept button will occur on the bottom line of the touch screen. You

will accept the measurements as correct by pressing this button and then continue with collection by pressing start.


line of the touch screen - after pressing the accept button), this view will show you the already measured results and values of the spirometric curve. WARNING! This is a premature termination of the examination, and it is impossible to continue further measuring after that.

� The BTL-08 Spiro will save and compare the results after three consecutive collections. If there are three correct

measurements received (by the accept button) – then the results from the measurements will be displayed on the screen, and the device will accomplish an automatic selection of the best curves according to the criteria SVC in relaxed profile.


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To finish the measurements, the stop button will appear during each procedure. In case of an unsuccessful measurement carry out the collection again by pressing the start button, if the test was accomplished correctly, choose accept and continue with measurements.

WARNING! Patients with COLD (Chronic Obstructive Lung Disease) can take a longer time to breathe out and may faint.

During and after the measurements, there are SVC, ERV, IRV and TV values displayed on the screen along with volume [V] / time [t] curve. All procedures are shown on the display, including a graphic chart of slow vital capacity for the best performed aspiration / expiration of the current patient, compared with a selected predictive value.


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3 I N S T R U C T I O N S F O R U S E

3 . 1 D E S C R I P T I O N O F T H E B T L - 0 8 S P I R O

3 . 1 . 1 K e y b o a r d a n d t o p p a n e l o f t h e d e v i c e


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Description of individual keys see chapter Function summary of keyboards buttons 1. printer cover 2. detent lever for the printer head 3. colour touch screen 4. battery level indicator (batt) 5. switch - on indicator (power) 6. storage battery charging indicator (charge) 7. discharged storage battery indicator (low batt) 8. printer error indicator (printer) 9. connector for patient ECG cable (possibility to extend the spirometry for ECG module) 10. part of the keyboard to operate the printer 11. part of the keyboard for setting record characteristics 12. pneumotachograph 13. ergonomic spirometer holder

3 . 1 . 2 R e a r p a n e l o f t h e d e v i c e

14. device switch – position 0 and I 15. connector for feeder cable connection 16. communication connector CS 232 to connect pneumotachograph 17. communication connector USB to connect personal computer (PC) or external printer 18. line fuse 19. manufacturing and type plate (placed on bottom cover of the device) 20. mains voltage switch 21. RESET button, programme restart, in case the device does not respond to pressing any key 22. clamp for device shielding (it is placed on the bottom cover of the device, only with the shouldered ECG module)


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3 . 1 . 3 P n e u m o t a c h o g r a p h d e s c r i p t i o n

Description of the parts: 23. – plastic mouthpiece (can be replaced by paper mouthpiece) 24. – spirometric sensor 25. – button to release spirometric sensor 26. – pneumotachograph 27. – silicone seal

3 . 2 D E V I C E A S S E M B L Y A N D P U T T I N G I N T O O P E R A T I O N

Unpack the device from the wrapping and place it on a firm flat surface, large enough to support the weight of the device. Do not expose the device to the direct rays of the sun. The device heats up during operation therefore it must not be placed near equipment that can heat up or generate heat. You must not place any objects producing heat on the device, or objects containing water, or any other liquid. Do not place the device near equipment producing a strong electromagnetic, electric, or magnetic field (diathermy, X -rays etc.); it could affect the operation of the device. In addition the recording paper, which is heat- sensitive, should be placed out of reach of thermal radiators (including direct sunlight) see chapter Storing conditions of thermal-sensitive paper. In case of any doubts contact the authorised service of BTL equipment. The BTL-08 spiro device is cooled by natural and compulsory air circulation. The cooling openings are placed under the device and around the printer, and must not be covered. Therefore do not put the device on a soft surface, so as not to cover or limit the air circulation to the lower cooling openings. We recommend that you keep the device packaging for eventual further transport of the device. Plug the device directly into the power mains supply; do not use extension cord with multiple connections or the adaptor.


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Switching the device on: Plug the power cord into the socket, switch toggle switch (see No.14 in chapter Rear panel of the device on the rear display) marked O/ I to position I and finally press the on/off switch on the keyboard. The switch - on indicator (5) will light up. Do not leave the power switch of the device (14) in position I, in order to charge the storage batteries. Storage battery charging: The device contains an internal storage battery, which is supplied in a semi - charged state. Therefore, after the device is purchased, we recommend to accomplish formatting the storage battery, i. e. to plug the device into the power mains supply with the toggle switch (14) in position I, for at least 48 hours non-stop. The device will be charged up and storage battery will be correctly formatted and recharged to the maximum level. A correctly formatted storage battery allows long-term operation of the device on one charge. For further information see Storage battery.

3 . 3 F U N C T I O N S U M M A R Y O F K E Y B O A R D B U T T O N S

Touch screen buttons, if displayed, provide the same functions as the buttons on the keyboard. The touch screen buttons can be pressed by the finger or by a special pointer with a soft tip, so - called touch screen pen pointer, which is a part of the standard accessories of the device. WARNING! The touch panel must not get into contact with any sharp instruments, ball-point pen, etc.

3 . 3 . 1 s t a r t

It is used to start the beginning of data collection for particular measurements. It is always necessary to enter all the important information about the patient before the initiation of the collection (see. menu - patient selection); otherwise it will not be possible to perform the whole measuring.

3 . 3 . 2 a c c e p t

Pressing the accept button confirms acceptance of the collected data of particular measurements, if the collection is unsatisfactory, press the start button again.

3 . 3 . 3 s t o p

This button is used to interrupt printing in progress. If the device is engaged with e.g. analysis, or measuring spirometric curves, the reaction of pressing the stop button can be delayed. In such cases wait, until the device finishes the performed operation and press the button again.

3 . 3 . 4 p r i n t

A report of the completed metering or measurement chosen from the database can be printed out by pressing this button; otherwise the collection will be saved in the memory of the device in the pre - set profile. If the device is engaged with e.g. analysis, or measuring spirometric curves, the reaction to pressing the print button can be delayed. In such cases wait until the device finishes the performed operation – the report “working ...” will stop showing on display - and press the button again.

3 . 3 . 5 a n a l y s e

Press this button to display the result of the analysis of the last collection. At the same time it is used to abort the examination of the patient - by pressing the button, the measuring will finish and it is not possible to continue the measurements again.

3 . 3 . 6 f o r c e d

By pressing the forced button you will confirm the selection of data collection in the forced profile.

3 . 3 . 7 r e l a x e d

By pressing the relaxed button you will confirm the selection of data collection in the relaxed profile.


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3 . 3 . 8 m v v

By pressing the mvv button you will confirm the selection of data collection in the mvv profile.

3 . 3 . 9 p r o f i l e

Choose one of the possible user-profiles that can be modified in the profile setup. The selection cyclically rotates over the actual profiles. The collection starts according to parameters preset in the memory of the device. The choice of an actual regime is indicated at the bottom status line of the display. Certain profiles can be selected also with the touch screen buttons directly on the display. Touch the screen in any place and the top and bottom toolbars with the control buttons will come up on the display. Pressing the touch screen, the profile button will show you the menu with the choice of all possible profiles in the device.

3 . 3 . 1 0 p a t i e n t

This button is used to activate the dialog box for entering data about a new patient. The data is saved by pressing enter. This data is printed in the record, at the same time saved in the device’s memory together with the collection, and can be selected from patients' file (see menu - select patient), where you can view them and eventually print them out on recording paper. Select the type of data from the menu that can be modified (filled in and saved), e.g. - device setup - patient record setup.

3 . 3 . 1 1 c a l i b r

Press the calibr button and enter calibration records submenu or use calib. button at the right bottom status bar on the display. Further selection in the calibration records submenu is controlled by the touch screen. There is possible to perform calibration or calibration verification. For detailed description of all calibration functions please see chapter Calibration.

3 . 3 . 1 2 c h i l d i n c e n t i v e

This is used to switch the stimulation on/off to motivate children during examination in the forced profile. A chosen picture is displayed on the right half of the screen. For the setup see menu – profile setup.

3 . 3 . 1 3 p r e d i c t v a l u e s

Enter to select the system of spirometry predictive values – resulting from the choice of expected values (e.g. Knudson, Roca, ECCS etc.)

3 . 3 . 1 4 c o n t r a s t

The button is used to set up the contrast quickly of the display. The contrast can also be changed at the device setup menu. Change of contrast of the colour display can modify the actual colour scheme.

3 . 3 . 1 5 m e n u

This button is used to enter the menu that includes the device setup, patients' data service etc. To enter the menu you can also use the touch screen. Touch the screen at any place and the top and bottom toolbars with the control buttons will come up on the display. Press the touch screen menu button (right bottom corner) or press the button on the keyboard and the device menu will appear.

3 . 3 . 1 6 u p - a r r o w / d o w n - a r r o w

These buttons are used to move the menu and eventually to change the values. The touch screen buttons, if displayed, provide the same functions as on the keyboard.

3 . 3 . 1 7 e s c

This button is used to cancel the choice or to return to a higher dialog box in the menu without saving the entered values. The touch screen button, if displayed, is used the same way as on the keyboard.


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3 . 3 . 1 8 e n t e r

The button is used to confirm the selection and saving the values or to enter the lower dialog box of the menu. The touch screen button, if displayed, provides the same function as on the keyboard.

3 . 3 . 1 9 o n / o f f

The button is used to switch the device on and off. When switching off, the device monitors the state of the storage batteries; if the batteries are discharged, the device will switch into charging mode, with power and charge indicators on. When the storage battery is recharged, the device will automatically switch off completely. This applies only if the device is plugged into the power mains and the toggle switch (14) on the rear panel is in position I. if it is not connected, or the switch (14) is in position 0, the device will switch off completely. Note It may take some time to recognize the condition of the storage battery; therefore the device can respond with a certain delay when switched off and immediately switched on again. All the saved data of the device is kept in the memory even during power shutdown.

3 . 3 . 2 0 p a p e r f e e d e r ( F F – f o r m f e e d )

This button is available only on the touch screen. Touch the screen on any place and the top and bottom toolbar with the control buttons will appear on the display. The FF button „ form feed „is in the left bottom corner. Press the button and the paper will come out of the printer. Depending on the type of paper, it will move out to the next page (z-fold paper), or about 3cm out (roll - paper). It is possible to press the button repeatedly. For more information on manipulation with the paper, see chapter Printer and paper.

3 . 3 . 2 1 d e v i c e r e s e t

If the device for some reason (electromagnetic disturbance etc.) stops responding to the user's instructions (keyboard, touch panel) and there is no 'wait please' sign with moving squares, then it is possible to put the device into an initial state by pressing the reset button (18) on rear panel of the device. After this action the device will restart immediately. Then it is possible the carry working with the device. Note If the device is in this state (i. e. “no response") the button on / off malfunctions too. The only help is to press the reset, see above.

3 . 4 P R I N T E R A N D P A P E R

The printer uses thermal - sensitive paper for the record. The paper quality can significantly influence the quality of print. For a high - quality record we advise to use only paper recommended by the BTL Company.

The yellow indicator (8) displays an error condition, which occurred in the printer. It can be caused by:

� missing paper � faulty pressure of the printer head on the paper ( detent lever of the printer head (2) is in the unlocked position; by

turning the detent lever leftwards, the head will lock and will be ready for printing). � inaccurately closed printer cover, the use of unsuitable paper type or setup of inadequate paper type. Error message with additional information is displayed on the screen together with the indicator. Another possible way of printing is the connection of an external printer through a USB interface. The USB connector is located on the rear panel (17) and it is designed to connect the PC and/or printers. Detailed description of the printer selection, see below.


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3 . 4 . 1 P a p e r s e n s i t i v i t y

Every paper type is slightly different, depending on sensitivity to thermal impulses produced by the printer. The final print can be too light and illegible, or opposite too dark, almost burnt (it is displayed as white centre inside the printed line). For these reasons, the device allows it to adapt to different paper types. Paper sensitivity can be set in the menu – device setup - paper and print setup, at the entry paper sensitivity. The more sensitive paper is set, the lighter the print will be in the end. There are 5 sensitivity setups available altogether. The best is to always try a suitable setup on a couple of prints when changing the paper type.

3 . 4 . 2 R o l l p a p e r w i t h r a s t e r

The device can print on thermal - sensitive roll paper with raster of 112 mm nominal width (see. chapter Technical specifications). For a high - quality record we recommend to use paper supplied by BTL companies only. Paper insertion: Remove the printer cover (1), move the detent lever (2) to the right, insert the paper into the paper container and place in front of the printer roller. Insert the end of the recording paper under the guide roller and the printer mechanism will start to draw the paper in automatically. Close the paper container cover and return the detent lever left. Crooked or an unevenly torn end of the inserting paper can obstruct automatic pulling of the paper, or the detent lever position – must be completely to the right – of the end. The paper feeder button, or the next page shift (FF – form feed) is available also on the touch screen in left bottom corner. By pressing this button, the paper can be released any time from the device. Tearing the paper: We recommend to tearing the roll paper away by pulling it directly from the bottom paper margin across the tear - off edge towards the display. ATTENTION It is absolutely essential to fold and insert the new paper very carefully and exactly parallel with the tear - off edge (raster on paper must be exactly in parallel with the tear - off edge); otherwise the paper will descend sidelong during unwinding, or will crush inside and tear.

3 . 4 . 3 U S B p r i n t e r s e t u p

Pressing the USB printer setup button will open the dialog box for the printer selection, which includes following entries: print resolution for printers connected through USB - resolution (dpi), the button for printing a test copy on the printer connected through USB – printer test and information on a printer currently connected to the device. The description of currently connected USB equipment includes: the equipment manufacturer, supported languages, available memory or maximum resolution supported by the printer. In some cases, this information can be inaccessible, e.g. if the printer connected to the device is not supported or equipment (other than a printer) is connected to the device. The maximum recommended length of a USB cable is 1,5 m. Printer requirements:

� interface USB1.1 or USB2.0 � PCL5 language � compatible with HP DeskJet or LaserJet

ATTENTION Some printers, that are not fully compatible with USB standard, may not be recognized by the device and can cause slow data transmission through USB. This current version does not support the printer model HP LJ 1022. Actual information on compatible printers is available at your BTL device supplier.


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3 . 4 . 3 . 1 r e s o l u t i o n ( d p i )

This item is used to change the resolution applied in USB printer. We recommend 200 dpi for faster print. Resolution 300 dpi is intended for high - quality printing. Print a test copy to find the suitable resolution for your printer.

3 . 4 . 3 . 2 p r i n t e r t e s t

Only the USB printer can print a test copy for detection of correct interface and setup. The test page includes: dimensions to find correct resolution, used resolution, description of the USB printer and a description of the device. Compare the actual measurements of the printing area with the dimensions printed on the paper and find out, if the selected resolution was correct.

3 . 4 . 4 S t o r i n g c o n d i t i o n s o f t h e r m a l - s e n s i t i v e p a p e r

The device prints on thermal - sensitive paper. To achieve the longest time stability of the printed record, it is absolutely necessary to keep the following conditions for storing the new and the printed paper: � storage temperature 25°C and lower � relative humidity 65% and lower � do not expose the paper to the sunlight � do not expose the paper to long - term radiation of fluorescent sources (fluorescent tubes etc.) � prevent the paper from contact with alcohol based glue (or esters, ketones etc). Use only starch, PVA or CMC

based dispersive glue. � prevent the paper from any direct contact with PVC packing material. This packing contains material based on

esters that can damage the thermal - sensitive coat of the paper and cause disappearance of the record.

3 . 5 S T O R A G E B A T T E R Y

The type of the storage battery is mentioned in chapter Technical specifications. An authorised customer service of the BTL device provides replacement of the battery. The storage battery is continuously recharged during the operation of the device from the power mains. Charging and maintenance of the battery in the charged condition is also in progress when the device is switched off, but it is connected to the power mains and power switch (14) on the rear panel in position I. When switching off, the device checks the charging condition of the storage battery and if the battery is discharged, then the device will be turned into charging regime, the display will be switched off and the power and charge indicators will be on, see chapter Keyboard and the top panel of the device. When the storage battery is recharged, the device will automatically switch off completely. This applies only if the device is plugged in the power mains and the toggle switch (14) on the rear panel is in position I. Finding out the condition of the storage battery lasts a while, therefore the device can respond with a certain delay during switching-off and immediately switching-on again. Complete storage battery recharge is achieved after about 6- hour charging – preferably overnight. The discharged storage battery is indicated by two signalling levels. � the storage battery is almost discharged, but it can still briefly print – the low batt indicator (7) flashes � the storage battery is discharged, the device disables the printer to print – the low batt indicator (7) lights up

permanently and at the same time the device makes a warning signal (short intermittent bleep 1x about every 20 seconds). The audible alarm can be turned off, see chapter Battery level indicator.

It is possible, that the device will not be able to print the whole spirometric record, if the storage battery discharge condition is indicated. Printing can be interrupted during the collection of data. Nevertheless the data is saved in the device memory and can be printed after the storage battery is recharged. To extend the effective life of the storage battery, we recommend keeping it permanently charged. At any chance, connect the spirometer to the power mains and turn the power switch (14) to the position I. The indicator (6) will switch on and will switch off when recharged, and the storage battery will be automatically maintained in a charged condition.


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If the device is disconnected from the mains or is in the switched off position for a longer time, then the storage battery gradually and spontaneously discharges. This effect is a characteristic of the applied storage battery and cannot be removed, therefore if the device was switched off and disconnected for more than about 2 - 3 months, we advise to recharge the device, preferably 48 hours non-stop. For the same reason we recommend to charge the device immediately after purchase, continuously for at least 48 hours regardless of the storage battery level indicator (you can use the device as normal, except do not unplug the device from the power mains, the storage battery is charged up even during standard operation of the device). The storage battery will format itself and the device will last longer in operation during one recharge.

3 . 6 L I T H I U M B A T T E R Y

The device includes a lithium battery for date and time backup. The type of the battery is mentioned in chapter Technical specifications. Replacement of the battery is provided by an authorised customer service of the BTL device.


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4 C O U R S E O F E X A M I N A T I O N

When switched-on, the device will start in the preset profile. It is possible to set the profile in menu – profile setup. Default profile forced is preset by the manufacturer. Therefore, the graph of full expiratory and inspiratory loop - flow [F] / volume [V] and the graph of expiratory curve - volume [V] / time [t] will come up on display. The device is ready for direct data collection. The display also shows these buttons and information:

� menu � start � selected printing profile � FF (form feed)

4 . 1 P R O F I L E S E L E C T I O N F O R C O L L E C T I O N O F T H E S P I R O R E C O R D

The profiles are used for fast setup of the device and its instant preparation for measuring. There are preset specifications of the collection and the printer configuration. Parameters of the basic profiles are preset by the manufacturer. Profiles can be changed in the menu of the device as needed, or before each examination, but not during measuring. Performed changes can also be saved in the memory of the device. The device has 3 predefined basic profiles. The forced profile is used for examination of a forced vital capacity, relaxed profile for a slow vital capacity and mvv profile for maximum voluntary ventilation. Apart from these three profiles, it is possible to create and also set other profiles (their selection is cyclic by pressing the profile button). The collection of spirometric examination starts by pressing the start button. The collection finishes automatically after a lapse of time set in the profile, or by pressing the stop button. Depending on the set profile, the device can still be completing the data collection for some time, a circle with “working ..." sign is displayed on the screen. At this moment the device performs the analysis of recorded measurements and saves it in the memory of the device.

4 . 2 P A T I E N T S E L E C T I O N

During and at the end of the examination, the measured records are compared with the presumed values that depend on some specifications of the patient – e.g. age, sex etc. The patient can be chosen from the patients' database or a new entry can be inserted (see menu – patient selection). The following minimum data about the patient is required to count the predictive values and the analysis of the spirometric curve: name, surname or ID, date of birth, sex and height. To specify the height of e.g. handicapped people, it is possible to also use the length of their arms (arm span).

4 . 3 P N E U M O T A C H O G R A P H I N T E R F A C E

Before the actual examination, you must insert the patient's part of the spirometry - pneumotachograph with the spirometric sensor and the mouthpiece to the connector (16) on the rear panel of the device. The connector is marked as RS232.


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4 . 4 E X A M I N A T I O N P R O C E D U R E

� Switch the device on by pressing on /off button. � Choose the printing record profile – menu – profile setup – forced (relaxed or mvv) and follow the instructions

on the display of the device. The examination includes the completion of at least three correct (accepted) measurements (procedures).


of the predictive values and for the record analysis - press the patient button. � Check the cleanness of spirometric sensor and measuring wire-gauze. � Initiation of the signal collection will start by pressing the start button. � The collection finishes automatically after an exact lapse of time in a certain profile (if activated - see examination

in set profiles) or by pressing the stop button. � Directly after the first achieved procedure, the accept button will appear on the bottom line of the touch screen.

You will accept the measurements as correct by pressing this button and then continue with the collection by pressing start.

� A view of the records from the first procedure can be obtained by the analyse button (displayed on the bottom

line of the touch screen - after pressing the accept button), this view will show you the current measured results and values of the spirometric curve. WARNING! This is a premature termination of the examination, and it is impossible to continue further measuring after that.

� The BTL- 08 Spiro will save the results from three consecutive collections. If there are three correct

measurements received (by the accept button) – then the results from the measurements will be displayed on the screen, and the device will accomplish an automatic selection of the best curves according to the criteria FEV1 + FVC in the forced profile, according to the criteria SVC in the relaxed profile and according to the mvv criteria in the mvv profile.

4 . 4 . 1 E x a m i n a t i o n i n f o r c e d p r o f i l e

This is an examination, when the display shows a graphic chart for the complete expiratory and inspiratory loop: - flow [F] / volume [V] - volume [V] / time [t] (only expiratory part of the curve)

- and eventually a motivational picture for children

Course of examination scheme:

SWITCH ON device on/off – CHOOSE PROFILE (FORCED) – ENTER PATIENT'S DATA – START COLLECTION start button – AUTOMATIC FINISH.

Before starting the record, check or adjust and set these parameters – they cannot be changed during record: � clean and absolutely dry the spirometric sensor and measuring net � required profile � clinical parameters (spiro parameters) � selection of the test type (bronchodilator, bronchoconstrictor test) � type of dosage � choice of inspiratory and expiratory forced spirometry (complete spirometry) / expiratory forced spirometry

(expiratory) The examination will be automatically finished after the time (set in profile) is up, it can be also stopped at any time by the stop key. If the actual measuring is accepted, confirm it by pressing the accept button. Press the print keys. The device will start printing the results of the gained values during measuring on thermal paper. The measurements are automatically stored in the record files!


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Evaluation of both tests: The basic examination ends with the acceptance of three procedures. Then a table is displayed next to three valid procedures (graphics) in the flow/volume graphic chart; the table includes measured values FEV1, FVC and PEF compared with the predictive values for individual procedures. At the same time the programme highlights the best curve. You can manually choose a different curve by clicking an appropriate procedure at the displayed table. At the same time there are reproducibility of FEV1, FVC and PEF parameters displayed (e.g. FVC+ means that FVC is reproducible, FVC- means that it is not reproducible).

4 . 4 . 1 . 1 I n s p i r a t o r y a n d e x p i r a t o r y f o r c e d s p i r o m e t r y ( c o m p l e t e )

� Switch the device on by pressing the on /off button. � Check, whether the spirometer is correctly calibrated. � Choose the printing record profile – menu – profile setup – forced and follow the instructions on the display of

the device. The examination includes a fulfilment of at least three correct (accepted) measurements (procedures). � Make sure, that the selection of the complete spirometry is switched on - menu - profile setup - forced - adjust -

spirometry mode - inspiratory and expiratory forced spirometry (complete). � Enter the patient's name and data (date of birth, sex, weight, height and race); this will be used for the calculation

of the predictive values and for the record analysis - press the patient button. � Explain carefully to the patient the course of the test, eventually demonstrate the test clearly. � Ask the patient about possible contra - indications, recent illnesses, used medicaments and whether the patient is

a smoker or a non-smoker. Measure the weight and height of the patient (without shoes) - height of the handicapped people can be also measured as length of their arms (arm span).

� Make sure, that the patient takes off any tight clothes, as this could misrepresent the test results. � The patient should sit comfortably throughout the test with his/her head slightly bent forwards. Spirometric sensor

has to be at horizontal position. � Ask the patient to put the nose clip on and check the tightness by requesting the patient to breathe through their

nose. � Pass the patient the spirometric module. The patient must grasp the spirometric module preferably with both

hands and his/her lips must hold the spirometer mouthpiece on the outside. � Ask the patient to breathe calmly and casually. � Check the cleanness of spirometric sensor and measuring wire-gauze. � Start the measurements by pressing the start button. � Ask the patient to breathe calmly and maximally into the pneumotograph and straight after that to do a maximally

forced aspiration and maximally forced expiration - and at the same time encourage the patient by saying "more and more" and "even deeper" in the stages of maximum aspiration and expiration.

� Let the procedure finish either automatically or by pressing the stop button. � The report on the quality of the procedure on the display of the device will help you to accept or refuse the

accomplished procedure. Inform the patient, how to do the next procedure well or even better, and assure him/her, that procedure was performed correctly. In the case of an unsuccessful measuring, perform the collection again by pressing the start button, if the test was performed correctly, choose accept and continue with measuring. We recommend accomplishing 3 consecutive measurements for a correct comparison of the results.

� Give the patient enough time to relax (15 - 30s) between the repeated procedures, otherwise the patient will not

be able to perform another forced aspiration and expiration which can lead to hyperventilation of the patient.


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� Repeat it all, until there are at least three procedures accepted or the test is finished prematurely by pressing the

analyse button (displayed on the bottom line of the touch screen after pressing the accept button). The total number of procedures should not exceed eight.

� Check the reproducibility of FVC, FEV1 and PEF parameters. � Carefully take the mouthpiece and the nose clip from the patient using a piece cloth to avoid direct contact with

your skin and the mouthpiece.

4 . 4 . 1 . 2 E x p i r a t o r y f o r c e d s p i r o m e t r y ( e x p i r a t o r y )

� Switch the device on by pressing the on /off button. � Check, whether the spirometer is correctly calibrated. � Choose the printing record profile – menu – profile setup – forced and follow the instructions on the display of

the device. Examination includes a fulfilment of at least three correct (accepted) measurements (procedures). � Make sure, that the selection of the complete spirometry is switched on - menu - profile setup - forced - adjust -

spirometry mode - expiratory forced spirometry (expiratory). � Enter the patient's name and data (date of birth, sex, weight, height and race); this will be used for the calculation

of the predictive values and for the record analysis - press the patient button. � Explain carefully to the patient the course of the test, eventually demonstrate the test clearly. � Ask the patient about possible contraindications, recent illnesses, medicaments used and whether the patient is a

smoker or a non-smoker. Measure the weight and height of the patient (without shoes) - height of the handicapped people can be also measured as length of their arms (arm span).




hands. � Ask the patient to breathe calmly and casually. � Check the cleanness of spirometric sensor and measuring wire-gauze. � Start the measurements by pressing the start button. � Ask the patient to maximally forcefully inspire (aside the spirometric module), immediately after that enclose the

mouthpiece of the spirometer in his/her lips and maximally narrowly breathe into the spirometric module. Encourage your patient during his/her maximal expiration by saying "more and more" and "even deeper".

� Let the procedure finish either automatically or by pressing the stop button. � The report on the quality of the procedure on the display of the device will help you to accept or refuse the

accomplished procedure. Inform the patient, how to do the next procedure well or even better, at the end assure him/her, that the procedure was performed correctly.

� Give the patient enough time to relax (15 - 30s) between the repeated procedures, otherwise the patient will not

be able to perform another forced aspiration and expiration which can lead to hyperventilation of the patient. � Repeat it all, until there are at least three procedures accepted or the test is finished prematurely by pressing the

analyse button. The total number of procedures should not exceed eight. � Check the reproducibility of FVC, FEV1 and PEF parameters.


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� Carefully take the mouthpiece and the nose clip from the patient using a piece cloth to avoid direct contact with

your skin and the mouthpiece.

4 . 4 . 2 E x a m i n a t i o n i n r e l a x e d p r o f i l e

An examination in the relaxed profile will test the changing volume of lungs at the beginning of a relaxed expiration – when the lungs are completely filled, to the end of expiration – when the lungs contain only a residual volume and opposite. Course of examination scheme:

SWITCH ON device on/off – CHOOSE PROFILE (RELAXED) – ENTER PATIENT'S DATA – START COLLECTION start button – AUTOMATIC FINISH

Before starting the record, check or adjust and set these parameters – they cannot be changed during the record: � clean and absolutely dry the spirometric sensor and measuring net � clinical parameters (spiro parameters) � required profile

The examination will be automatically finished after the time (set in profile) is up, it can be also stopped any time by the stop key. If the actual measuring is accepted, confirm it by pressing the accept button. Press print keys. The device will start printing the results of the gained values during measuring on thermal paper. The measurements are automatically stored in record files! � Switch the device on by pressing on/off. � Check, whether the spirometer is correctly calibrated. � Explain carefully to the patient the course of the test, eventually demonstrate the test clearly. � Choose the printing record profile – menu – profile setup – relaxed and follow the instructions on the display of

the device. The examination includes the completion of at least three correct (accepted) admeasurements (procedures).


of the predictive values and for the record analysis - press the patient button. � Ask the patient about possible contra indications, recent illnesses, medicaments used and whether the patient is a

smoker or a non-smoker. Measure the weight and height of the patient (without shoes) - height of the handicapped people can be also measured as length of their arms (arm span) i.e. the maximum distance between the tops of their middle fingers.




hands and his/her lips must hold the spirometer mouthpiece on the outside. � Ask the patient to breathe calmly and casually. � Check the cleanness of spirometric sensor and measuring wire-gauze. � Start the measurements by pressing the start button. � When the curve crosses the first vertical dashed line (at least 6s after pressing the START button), ask the patient

to perform a quick, but not hard maximal aspiration followed by instantaneous maximal slow expiration (so - called EVC procedure) - encourage the patient during his/her maximal aspiration and expiration by saying "more and more" and "even deeper".

� Let the patient breathe calmly again.


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� Before the curve crosses the second dashed line, ask the patient, to perform maximal slow expiration followed by

instantaneous fast, but not forced maximal aspiration (so - called IVC procedure) - once again encourage the patient during his/her maximal expiration and aspiration by saying "more and more" and "even deeper".

� Let the patient know the end of the procedure and let him/her breathe calmly again. � The procedure will finish either automatically in 30 seconds after pressing the start button or by pressing the stop

button. � Accept the correctly performed procedures. � Give the patient enough time to relax (15 - 30s) between the repeated procedures, otherwise the patient will not

be able to perform another forced aspiration and expiration which can lead to hyperventilation of the patient. � Repeat it all, until there are at least three procedures accepted or the test is finished prematurely by pressing the

analyse button (displayed in the bottom line of the touch screen after pressing the accept button). The total number of procedures should not exceed eight.

� Carefully take the mouthpiece and the nose clip from the patient using a piece cloth to avoid direct contact with

your skin and the mouthpiece. To finish the measurements, the stop button will appear during each procedure. In case of an unsuccessful measurement carry out the collection again by pressing the start button, if the test was accomplished correctly, choose accept and continue with measurements.

WARNING! Patients with COLD (Chronic Obstructive Lung Disease) can take a longer time to breathe out and may faint.

During and after the measurements, there are SVC, ERV, IRV and TV values displayed on the screen along with the volume [V] / time [t] curve. All procedures are shown on the display, including a graphic chart of slow vital capacity for the best performed aspiration / expiration of the current patient, compared with a selected predictive value.

4 . 4 . 3 E x a m i n a t i o n i n m v v p r o f i l e

The examination in mvv profile will test the maximal air volume breathed out during voluntary ventilation. This measuring uses the volume [V] / time [t] graphic chart. Course of examination scheme:

SWITCH ON device on/off – CHOOSE PROFILE (MVV) – ENTER PATIENT'S DATA – START COLLECTION start button – AUTOMATIC FINISH.

Before starting the record, check or adjust and set these parameters – they cannot be changed during the record: � clinical parameters (spiro parameters) � required profile

� Switch the device on by pressing on/off. � Check, whether the spirometer is correctly calibrated. � Explain carefully to the patient the course of the test, eventually demonstrate the test clearly. � Choose the printing record profile – menu – profile setup – mvv and follow the instructions on the display of the

device. The examination includes the completion of at least three correct (accepted) admeasurements (procedures).


of the predictive values and for the record analysis - press the patient button. � Ask the patient about possible contraindications, recent illnesses, medicaments used and whether the patient is a

smoker or a non-smoker. Measure the weight and height of the patient (without shoes) - height of the handicapped people can be also measured as length of their arms (arm span) i.e. the maximum distance between the tops of their middle fingers.

� Check the cleanness of spirometric sensor and measuring wire-gauze.


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� Spirometric sensor has to be at horizontal position. � Tell the patient firstly to breathe calmly, and then ask him/her to start breathing with maximal depth and frequency

for a period of 15 seconds. � Press the start button to start the testing. � The patient breathes calmly. When the displayed curve crosses the first dashed line (6s after the start of

measuring), ask the patient to breathe with maximal depth and frequency and encourage the patient until the curve crosses the second vertical line (21s after the start of measuring).

� After that, the patient can go back to slow breathing. Keep the ideal breath frequency of 90 - 110 breaths per

minute during the actual measuring, according to the condition of the patient. We recommend using the nose clip. � The examination will finish automatically after a lapse of time pre - set in the profile; it can be also cancelled any

time by pressing the stop button. To confirm the actual measuring, press the accept button. � To finish measurements, the stop button will appear during each procedure. In case of an unsuccessful

measurement carry out the collection again by pressing the start button, if the test was accomplished correctly, choose accept and continue with measurements.


line of the touch screen - after pressing the accept button), this view will show you the current measured results and values of the spirometric curve. WARNING! This is premature termination of examination, and it is impossible to continue in further measuring after that.

� The BTL-08 Spiro will save the results from three consecutive collections. If there are three correct measurements

received (by the accept button) – then the results from the measurements will be displayed on the screen Volume [V] - time [t] curve and a table with the measured parameters compared with the predictive values for every accepted procedure are subsequently displayed on the screen during the measuring. After accepting the third procedure, the table in the column ‘Best’ will be completed with the biggest values of the measured parameters. The measuring is considered to be sufficient, if the variability between the received procedures does not exceed 20%. Press the print keys. The device will start printing the results of the gained values during the measuring on thermal paper. The measurements are automatically stored in the record files!

4 . 5 B T P S C O R R E C T I O N

Air passing through the pneumotachograph during aspiration has a certain temperature, relative humidity and pressure, corresponding to the conditions of the room, where the measuring is provided. These conditions are referred to as ATP (ambient temperature and pressure). Air in the lungs will warm up to the body temperature and will saturate with water vapour to almost 100% - so-called BTPS conditions (body temperature and pressure saturated with water vapour). This effect will change the air volume in the lungs. Therefore the spirometric values are re-counted for BTPS conditions, to compare the gained results under different ambient conditions. The pneumotachograph BTL- 08 Spiro includes all the needed sensors – they measure temperature of the ambient air, relative humidity and barometric pressure – so the device is able to do the ATP correction for BTPS automatically.

4 . 5 . 1 A T P c o n v e r s i o n i n t o B T P S

The resultant values in spirometry are indicated in values converted to BTPS.

VBTPS = VATP * (Tbody / Tamb) * { [ pamb – pH20(Tamb, Hamb) ] / [pamb – pH20(Tbody, Hbody) ] }


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Where: VBTPS – gas volume converted to BTPS conditions

VATP – gas volume measured at ATP conditions Tbody – human body temperature in Kelvin (310 K) Tamb – ambient temperature in Kelvin pamb – atmospheric pressure at ATP conditions pH20(Tamb, Hamb) – vapour pressure at ATP conditions pH20(Tbody, Hbody) – vapour pressure at BTPS conditions is 6282 Pa, i. e. 47 torr Hamb – elative humidity Hbody – relative humidity in the lungs (100 %)

4 . 5 . 2 M e a s u r e m e n t r e l i a b i l i t y a n d I N T E R P R E T A T I O N

We consider the parameters to be correct, if they were evaluated from the correctly performed procedures on a properly calibrated device and under the conditions suitable for the patient. Therefore it is the operator's responsibility to check the physical environmental conditions and also the calibration validity. Then after the completion of each procedure, the operator is asked to evaluate it – either the procedure is accepted or there will be another one performed. In the forced profile the operator will automatically receive additional information on the FVC procedure on the display - verbal classification (e.g. breathe out faster), and reproducibility of some parameters (FVC, FEV1 and PEF). For these and other reasons the operator of this device should be properly and regularly trained.

The device in the forced profile provides an automatic interpretation of the results (Enright, BTS, ATS) on the basis of entered data about the patient and a selected system of the predictive values. It is at the most advisable to double-check the accuracy of the entered specifications about the patient (age, sex, height etc.). However, it is up to the operator and every doctor to take into consideration, how to use the results of this automatic interpretation.

It is necessary to mention, that the device, and especially the measuring net of the pneumotachograph, must be properly taken care of, in particular keeping the device clean. Otherwise, some or all the parameters can be unreliable regardless of the results of the calibration.

4 . 5 . 3 M e a s u r e m e n t r e s u l t s a n d t h e i r a c c e p t a n c e ( F V C m e a s u r e m e n t )

The measurement results are acceptable, if: � they are without

o coughing o closure of the vocal cords in the first seconds of expiration o early interruption of expiration o different intensity (consecutive measurements should not dramatically vary) o escaping of air around the mouthpiece or through the nose o blocked mouthpiece (e.g. with tongue)

� they have a good start

o the volume removed by reverse extrapolation is lower than 0,15 l for FVC ≤ 3 l 5 % FVC for FVC > 3 l

o time until PEF is lower than 120 ms � expiration

o the graphic chart volume / time finishes with a horizontal curve, that lasts „ a reasonable time" (volume – time curve changes more, than 0,025 l per 1 second and longer time, and the patient exhaled longer than 3 seconds = for children up to 9 years included and longer than 6 seconds = for a patient 10 years included or older) or

o the patient cannot continue with expiration any more � the three accepted measurements must comply with these tests

o the difference of the two biggest values FVC is lower than 0.15 l o the difference of the two biggest values FEV1 is lower than 0.15 l o if the previous two criteria are not executed, follow these procedures:

� collect additional measurements and examine, whether the above mentioned criteria will are fulfilled � the total number of measurements is already 8 � the patient cannot continue any more

� the best curve will be chosen automatically, according to the criteria of the biggest total of FEV1 +FVC values and the subsequent parameters will be calculated from this curve


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� print of the best values FVC and FEV1 can be also selected to the resultant table – so - called Best FVC and Best FEV1

Evaluation of the measurement acceptance according to A.R.R.D. [1]: Qualitative aspect Criterion Faster start VEXT > 5% of FVC and > 150ml More intensive expiration PEFT > 120 ms [1] or PEFT > 85 ms Without coughing 50% flow drop in the first second Longer expiration FET100% < 6 s Deeper expiration flow > 0.2 l/s up to 20 ml FVC More intensive expiration dPEF > 10% Deeper aspiration dFVC > 200ml and 5% best FVC Faster expiration dFEV1 > 200ml and 5% best FEV1 Good test with no errors FVC reproducibility at least 3 accepted procedures. Difference of the 2 biggest FVC up to 0.2l for

each of them FEV1 reproducibility at least 3 accepted procedures. Difference of the 2 biggest FEV1 to the 0.2l

for each of them PEF reproducibility 2 biggest PEF up to 10 % MVV too short test MVV time shorter than 12s Algorithms for a verbal evaluation of the record according to Enright and BTS algorithms, mentioned in the figure, see below: Note: FER=FEV1/FVC

ENRIGHT INTERPRETATION

Start

Check the quality of the procedure

FER under LLN?

FEV1 above LLN?

FEV1 above 60 % predict. values?

FEV1 above 40 % predict. values?

FVC under LLN?

FVC above 60 % predict. values?

FVC above 50 % predict. values?

yes

no

no

yes

yes

yes

boundary obstruction

slight obstruction

mild obstruction

serious obstruction / spirometry

no

no

no

no

common spirometry

slight

spirometry

mild spirometry

no

yes

yes

BTS INTERPRETATION

Start

Check the quality of the procedure

FER < 70%?

FEV1

FEV1 < 60 % predict. values?

< 80% predict. values?

FEV1< 40 % predict. values?

FEV1 a FVC <80% predict. values?

FEV1 <80% predict. values?

FEV1 <80% predict. values?

no

no

no

yes

yes

yes

yes

no

no

no

no

yes

yes

yes

restrictive disorder

common spirometry - reduced FEV1

common spirometry - reduced FVC

common spirometry

common spirometry

slight obstruction

mild obstruction

serious obstruction


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5 S E T U P M O D E

5 . 1 M A I N M E N U

Enter the main menu from the regime of monitoring the aspiratory curves, by pressing the menu button. You can enter the menu also through the touch screen. To enter the main menu of the device, press the touch screen button with the menu sign (bottom right on display). You can choose from these options: � records file (data management) � profile setup � calibration � device setup � patient selection � doctor selection

5 . 1 . 1 R e c o r d s f i l e

This menu allows recalling, viewing and printing the last performed collections. The collections are saved in the memory of the device automatically. In case the memory is full, the next performed collection will overwrite the oldest record stored in the memory. The records marked as archive (the mark button; + sign is displayed in front of the record), always stay in the memory of the device and are not overwritten (that means they must be deleted manually). You can do the following operations with the chosen record: � print it repeatedly with a selected setup, as it was collected � view the record on display � mark/re-mark the record as archive � delete a selected record or all the records together � display the records in optional order according to the attribute - archive, date, name, or personal identification

number Note: The records are saved in the memory of the device in compressed form, in order to enter as many records in the device as possible; therefore during the first archive entry the device must convert the records into a readable form. This operation may even last several seconds depending on the number of saved records.

5 . 1 . 2 P r o f i l e s e t u p

The profiles are used for a quick setup of the device and its immediate preparation for printing. They are preset parameters of the collection and printing configurations. The parameters of the basic profiles are preset by the manufacturer. The profiles can be set in the device menu before each examination, but not during measuring. The device has 3 basic profiles: � forced profile (button forced) is used for examination of forced spirometry, � relaxed profile (button relaxed) for relaxed spirometry and � mvv profile (button mvv) for maximal voluntary ventilation. Apart from these three, even other profiles can be created (it is a cyclic selection by pressing the profile button) the existing profiles can be modified or eventually deleted (except the basic profiles, that cannot be deleted)


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5 . 1 . 2 . 1 F o r c e d , r e l a x e d a n d m v v p r o f i l e p r o p e r t i e s s e t u p

For each profile you can preset some of these parameters according to the type of profile: � name of the profile (can be changed only for user profiles) � type of the profile (can be changed only for user profiles) � predictive values (according to experimentally gained and evaluated measurements – for a description see

chapter Predictive values) � spirometry parameters according to type of the profile � automatic printing (selection on / off automatic printing after the end of measuring) � print setup

o data printed in the record header (setting the printing header) o interpretation in header (print / no print) o spirometry graphic charts (print / no print) o printer type (internal / external - USB)

� automatic stop (the test is / is not automatically finished after a lapse of time, which is recommended by the document [3] ATS / ERS 2005, see chapter List of used literature)

� interpretation (choice of Enright, BTS or ATS) � broncho-dilatation test

o name of broncho-dilatation material o type of dosage (ug or mg/ml) o quantity

� broncho-constriction test o name of broncho-constrictive material o type of dosage (ug or mg/ml) o protocol

� spirometry mode o inspiratory and expiratory forced spirometry (complete) o forced expiratory spirometry (expiratory)

5 . 1 . 3 C a l i b r a t i o n

When choosing the calibration, the following buttons are displayed: • syringe volume setup – setting the capacity of the calibration syringe (3 litres – syringe supplied by BTL) • calibration records – record database of performed calibrations • calibration setup – setting the total number of manoeuvres performed for calibration and check calibration Calibration records There is possible to enter, select, edit and delete all records of appropriated spirometric sensors.To this purpose we recommend to mark spirometric sensors with a number. Entrance to this menu is possible from on-line mode as well by pressing of calibr key, eventually by pressing calib button on the touch panel. Further button calibrate enables to perform calibration of selected sensor. When specified spirometric sensor is selected it is possible to perform the verification of performed calibration by pressing the button calibration check at the bottom status bar of display. Calibration Connect the calibration syringe firmly with the spirometric module. Press the start button to initiate the calibration. Carry out a total filling and emptying of the calibration syringe (the best is the 3 litre capacity) according to the total number of set manoeuvres in three different speeds according to the instructions on the calibration cylinder on the display. After completion of the last manoeuvre, stop the calibration by pressing stop button and a table with data for individual calibration procedures and the resultant calibration coefficient for inspiratory and expiratory part will be displayed on the screen. Everything will be saved in the database of the calibration records. The calibration result is possible to print as well. Calibration check Connect the calibration syringe firmly with the spirometric module. Press the start button to initiate the verification of the calibration. Carry out total filling and emptying of the calibration syringe according to the total number of set manoeuvres, always at a specified speed according to the calibration syringe bar-diagram on the display. After completion of the last manoeuvre, finish the verification of the calibration by the stop button, and a table with data for individual calibration procedures and resulting deviation will appear on the screen. Everything will be saved in the database of calibration records.


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If this deviation is greater than 3,5%, then it is necessary to perform a new user calibration of the device. Verification of the calibration must be carried out at least 1x a day, or more often if necessary. For correct function of unit, we advise the operating staff to perform the calibration and verification regularly, the best is every day and after every replacement of spirometric sensor and always after its cleaning. Warning: Spirometric sensor connected to the pneumotachograph without inserted silicon seal is nit possible to calibrate! Calibration setup This submenu allows entering the total number of manoeuvres for performing of calibration or calibration verification. In both cases it is possible to select minimally three and maximally nine manoeuvres. We do recommend performing nine manoeuvres for calibration and three manoeuvres for calibration check.

5 . 1 . 4 D e v i c e s e t u p

In this submenu you can choose from the following items: • choose a profile, in which the device will start after switching-up (profile selection after the start) • set the track intensity of the spiro signal during printing (line width) • preset the information displayed on the patient's medical record (patient's record setup) • set up optional specifications of the patient (patient's optional specifications) • preset printing parameters and type of paper used (paper and printing setup) • information on the module • enter the next user setup menu of the device (user setup)

5 . 1 . 4 . 1 S t a r t i n g p r o f i l e – s e l e c t i o n o f p r o f i l e a f t e r s t a r t

You can choose a profile, which will be preset on the device immediately after activating it by the on /off button.

5 . 1 . 4 . 2 L i n e w i d t h

Here, you can set the track intensity for printing the spirometric curve. The setup needs to be adjusted according to the paper used. The setting only influences printing the actual spirometric curve, and not printing other information (texts, pictures). Optimal printing can be achieved through this setup together with setting the suitable paper sensitivity (see above).

5 . 1 . 4 . 3 M e d i c a l r e c o r d o f t h e p a t i e n t – p a t i e n t ’ s r e c o r d s e t u p

Activated items will appear when entering the patient's data and can be filled in. They are saved together with the patient. You can activate these items on the patient's medical record:

• name • surname • name 2 • identification number (personal identification number ) • date of birth • sex • weight • blood pressure • height • cardiac pacemaker • race • smoker • 2 user- defined items – their meaning and description can be set in Optional specifications of

the patient.

5 . 1 . 4 . 4 O p t i o n a l s p e c i f i c a t i o n s o f t h e p a t i e n t

In this part you can define names of two optional items in the patient's record – for example diagnosis, general condition...


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5 . 1 . 4 . 5 P a p e r a n d p r i n t s e t u p

You can find important parameters here relevant to printing. You can set the resolution of the USB printer, paper sensitivity and paper entry during the changeover. The paper sensitivity setup is important for optimal printing and together with the track width setup entirely influences the quality of printing. More about paper insertion is mentioned in chapter Printer and paper.

5 . 1 . 4 . 6 M o d u l e i n f o r m a t i o n

This part displays clearly all the crucial information about the configuration of the connected module. It is a serial number of the module, module type, firmware version, etc ... You will need this information in case of eventual communication with the business or service department.

5 . 1 . 4 . 7 U s e r s e t u p

5 . 1 . 4 . 7 . 1 T i m e a n d d a t e

Setting the date and time in the device. Date and time are saved together with the records and are printed out on the made records. The preset date and time of the device are of course stored in the memory even when storage batteries are discharged and the device is disconnected from power mains.

5 . 1 . 4 . 7 . 2 D i s p l a y c o n t r a s t

You can set up the required contrast of the display. The function is the same as when pressing the contrast button on the touch screen. The contrast is set by pressing the arrow on the touch screen, or on the keyboard. Note Regulation of the contrast on the colour display may change the colour presentation of the actual chromatic diagram.

5 . 1 . 4 . 7 . 3 L a n g u a g e o p t i o n s

This is a setup of language, in which the device communicates with you. The modification will always display when the device is switched on again.

5 . 1 . 4 . 7 . 4 T o u c h s c r e e n c a l i b r a t i o n

If the buttons on the display other than requested respond to buttons pressed on the touch screen, it is necessary to calibrate the touch panel. The calibration procedure is apparent from the screen of the device. It is advisable to use a touch pen pointer during the calibration and follow the instructions, marked on the screen of the device. If the calibration is unsuccessful, it can always be interrupted by pressing the esc button. The result of the touch screen calibration can be verified in the function “touch screen function test”. Direct initiation of the touch screen calibration from the keyboard can be done by entering the menu by pressing the start key.

5 . 1 . 4 . 7 . 5 F i l e s c o r r e c t i o n

Due to disturbance, or the device deficiencies, the saved data will get damaged and the device can indicate errors in the file system (loss of some records, loss of some saved patients). This function initializes diagnosis of the file system and tries to rectify the errors preferably without loss of the saved data. Depending on the number of saved data, the function can take a considerably long time (hours), therefore we recommend to run this function overnight etc. Once you start the function, you must wait for its completion, or reset the device, see chapter Function summary of keyboard buttons.

5 . 1 . 4 . 7 . 6 F i l e s s y s t e m f o r m a t

The function initializes the whole file system, i.e. it will delete all the saved data in the device and will put the device to the initialized position (starting position as when purchased). This function is used only during a major accident, or if the user wants to initialize the device completely.

5 . 1 . 4 . 7 . 7 D e f a u l t s e t t i n g w i t h o u t d a t a l o s s

The function will set the device into a state as when purchased (it will set the language, colours etc.) and at the same time will keep the saved data of the profiles, patients, doctors and records.

5 . 1 . 4 . 7 . 8 D e v i c e s l e e p m o d e i n t e r v a l

This will set up a length of downtime after which the device is switched off.


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5 . 1 . 4 . 7 . 9 B a t t e r y l e v e l i n d i c a t o r

You can switch on / off the audio alarm (short fast whistling) of the discharged battery. Visual indication cannot be switched off.

5 . 1 . 4 . 7 . 1 0 M o r e …

Press this button and you can continue with other user setup (more items): • device information – all crucial information on the device configuration is clearly displayed here. Such as the

serial number, firmware version, time when the device is restricted in its function, the temperature of single parts of the device, firmware version of the printing module and hardware key configuration. This information is needed when communicating with the business department.

• hardware key setup – configuration of the device can be remote-controlled. For the actual hardware configuration see menu device information.

• access password setup – to prevent the device from any unauthorized manipulation, you can activate the demand on entering the password when switching the device on. It is possible to turn the demand on password on/ off, or change the password. The password can be any long numeric combination. If you forget the password, always enter password 00000000.

• key sound - on /off function of key sound. • cancel the patient after the collection – yes / no option to cancel the entered patient immediately after the

collection. • save the actual doctor – yes / no option to store the name of the actual doctor. • other – more items of the user setup

o name of the hospital – function of inserting the name of the hospital, which will be printed out with the record.

o initial mode - mode, that will be selected immediately after the device start-up by the on /off button o colour schemes – setting the coloured versions of the display. There is a number of colour

schemes preset by the manufacturer, that you can edit or delete or create your own colour schemes. Every displayed item can have its own colour.

o colour of the curves - choice of colour front and background of the graphic chart, active and inactive curves. A number of colour schemes preset by the manufacturer, that you can edit or delete or create your own colour schemes. Every displayed item can have its own colour.

o default race of the patient – function of default setup of the patient's race

5 . 1 . 5 P a t i e n t s e l e c t i o n

The device contains a database of patients. It is possible to enter, edit and delete the patients. A new patient can be also entered in on - line mode by pressing the patient button. The entered values for the patient can be adjusted in the device setup, see chapter Medical record of the patient - patient record setting. The number of patients is limited only by the capacity of the memory. The patient's specifications are printed out in the header of the record according to the setup of the relevant profile. Saved patients stay in the memory even when the device is switched off. Function of the actual pre-set patient is always set empty when the device is switched on.

5 . 1 . 6 D o c t o r s e l e c t i o n

The device includes a database of doctors, which is used for setting, editing or deleting of entered doctors. The number of doctors is limited only by the capacity of the device memory. Data about the doctor is printed out in the footer of the record according to the setup of the relevant profile. Saved doctors stay in the memory even when the device is switched off. The function of actual pre-set doctor is always empty when the device is switched on.


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6 A C C E S S O R I E S

The device is not intended for use in connection with other equipment, with other medical appliances and instruments except those mentioned in this instruction manual. This list includes specifications of all equipment that can be supplied with the device. More detailed information on particular equipment can be found in the enclosed leaflet. Standard BTL accessories: • 4x spirometric sensor, plastic mouthpiece and silicone seal (set) C08SP.015v100 • 1x nose clip for BTL-08 Spiro C008.146 • 25x motivation pictures for children - elephant C08SP.016v100 • 25x motivation pictures for children - clown C08SP.017v100 • 1x CD with service instructions Other standard BTL accessories for Spiro Pro plus • 1x ECG paper 112mm, roll 25m C008.105v101 • 1x pen pointer for touch screen G000.099v101 • 1x power cord G000.051 • 1x table holder for BTL-08 Spiro C08SP.020v100 • 1x dust cover for the device • 1x spare fuse More standard BTL accessories for Spiro and Spiro Pro modules • 1x attach case Spiro C08SP.021v100 Optional BTL accessories: • 1x spirometric sensor, plastic mouthpiece and silicon seal (set) C08SP.015v100 • 1x calibration syringe for BTL-08 Spiro – capacity 3 litres C08SP.014v100 • 1x disposable paper mouthpiece* C08SP.012 • 1x antibacterial filter for BTL-08 Spiro C08SP.013 • 1x cart for BTL- 08 Spiro Pro Plus P5002.125v100 • 1x cart for BTL- 08 ECG Mx, Sx & Spiro P5002.123v100 • 1x cart for BTL- 08 ECG Lx & Spiro P5002.128v100

*disposable paper mouthpiece can be also bought in specialized shops. Significant parameters for compatibility with BTL spirometer are: mouthpiece length 71mm, inner ø 30mm, outer ø 33mm ** it is possible to buy standard accessories with listed supply number.


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7 M A I N T E N A C E A N D D E V I C E S A F E T Y

Maintenance inspection with measurements of all the parameters of the device and recalibration is necessary at intervals shorter than 30 calendar months. Inspections and recalibration are accomplished by authorised service of BTL the device on the basis of the user's order. If the inspection is not performed to a defined deadline, the manufacturer is not responsible for the technical parameters and safe operation of the product. Keep the device clean, do not store and use it long - term in extremely dusty environments and do not submerge it into any liquid. Check every time before using, that the device and its accessories (especially cables) are not mechanically or otherwise damaged. Do not use if the device is damaged! Fuse replacement The fuse is placed on the rear panel in a black round case (18). At first, make sure before the replacing, that the power switch (14) is in position “0", and then disconnect the power cord from the device. Turn the fuse case section leftwards by using a suitable screwdriver or a coin and remove the fuse. Insert the new fuse and finish the replacement in the similar way, but to the right. It is prohibited to insert a fuse with different specifications, than mentioned on the fuse case. This operation may only be done by a person acquainted with this procedure! Transport and storage We recommend to keep the packaging of the device. It is useful to wrap the device during transport in this wrapping, which provides maximum protection. Disconnect the power cord from the device and the accessory cables. Avoid major impact. Store /transport the device only under the conditions defined in chapter Technical specifications.

7 . 1 C L E A N I N G T H E D E V I C E S U R F A C E A N D I T S P A R T S

Clean the device and its parts with a lightly damped soft cloth only. To wash the device, use water or a 2 % detergent solution. Never use liquids containing alcohol, ammonia, petrol, thinners etc. To clean the device never use abrasive materials, as it could damage the surface of the device. None of the device parts are sterile and there is no need to sterilize them.

7 . 1 . 1 C l e a n i n g t h e t o u c h s c r e e n

The surface of the touch screen can be cleaned by cleaning agents suitable for monitors, or agents used for glass surfaces. These detergents can be applied only by spray gun. LIGHTLY spray the cleaning agent on the centre of the touch screen, wipe and polish the whole surface with a dry cloth. Press the cloth VERY GENTLY; otherwise the touch screen could break. ATTENTION The cleaning detergent must not get under the edges of the touch screen; otherwise it could damage the device. The cleaning detergent should not get into contact with any other parts of the device except the touch screen.

7 . 1 . 2 C l e a n i n g t h e p a p e r s e n s o r s

Every 6 months wipe off dirt and dust from the paper sensors with a soft brush or dry cotton ball. Sensors are placed under the printer cover near the upper edge of the device (two black squares) and are reachable when the printer cover is removed from the device.


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7 . 2 H Y G I E N E , C L E A N I N G A N D D I S I N F E C T I O N O F S P I R O M E T R I C A C C E S S O R I E S I N C O N T A C T W I T H T H E P A T I E N T

7 . 2 . 1 H y g i e n e

During the spirometric examination and especially after its completion, it is necessary to follow basic sanitary regulations suppressing a risk of possible infection. With respect to the possibility of microbes getting into the internal part of pneumotachograph through the silicon seal, we do recommend separating the pneumotachograph from spirometric sensor after each patient. Place the uncovered pnemotachograph preferably in the directions opposite to incoming patients - using the ergonomic spirometric holder or designed stacker plate of spirometric trolley. The pneumotachograph BTL-08 Spiro is designed for users to select a degree of protection according to their needs. The spirometer can be used in these configurations: • Disposable antibacterial filter – this is the safest use of the spirometer, all possible bacteria

and viruses get caught in the antibacterial filter that is used by one patient and then disposed, according to regulations valid for biological waste. Measuring equipment of the spirometer remains clean all the time. This technique also guarantees the most exact measurement, because the measuring sensor will not get contaminated.

• Disposable paper mouthpiece – using the paper mouthpiece lowers the risk of infection

transmission by direct contact. The paper mouthpiece must be used by only one patient and properly disposed of as biological waste. The measuring equipment of the spirometer must be cleaned, because it has been contaminated with the patient's breath – the best is to use disinfection or sterilization. We advise to disinfect / sterilize these parts immediately after using the pneumotachograph: spirometric sensor (24) and silicone seal (27) – see chapter Pneumotachograph description.

• Washable plastic mouthpiece – the below mentioned parts must be disinfected or sterilized

after each patient, and this way of using the spirometer can be also regarded as safe. After using, we advise to disinfect /sterilize these parts of the spirometer, after each patient: plastic mouthpiece (23), spirometric sensor (24) and silicone seal (27) – see chapter Pneumotachograph description.

If in any doubt about the possibility of infection / transmission of TBC, HIV or jaundice, we advise the implicit use of the disposable antibacterial filter. Potential infection transmissions are: Direct contact: possible chance of contamination with upper airways diseases, intestinal infections and blood transmitted infections (including jaundice and HIV). Infection transmission is possible through disposable microbial filter, pneumotachograph mouthpiece or through the measuring mechanism (if the microbial filter is not used). The mentioned parts cannot only be contaminated with saliva, but also with blood from open ulcers and scratches in the mouth and bleeding gums. Indirect contact: the potential possibility of contamination with tuberculosis, viral infections etc., transmitted by droplets The most contaminated device parts: disposable antibacterial filter, mouthpiece and measuring mechanism (if the microbial filter is not used).


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Prevention: • personnel: it is recommended to use protective gloves when handling the spirometer or washing and cleaning

the contaminated parts, also hands should be washed, immediately after work with the spirometer • patients – protection from cross contamination:

o using disposable antibacterial filter o equipment parts that get in direct contact with the patient (antibacterial filter, mouthpiece, nose

clip ), it is advisable to dispose of them after using, or in the worse case sterilize / disinfect o sterilization or disinfection of all reusable parts that come into contact with exhaled and inhaled

air (measuring mechanism) – we recommend to carry out sterilization or disinfection after every patient

o threat of risk of transmission of tuberculosis, or similarly aggressive diseases (e.g. HIV, jaundice), we recommend using the disposable antibacterial filters during the measurement

o it is advisable to use a flow of air after sterilization / disinfection to remove droplets of water from the measuring mechanism of the spirometer

o it is necessary to remember to accomplish calibration , after every sensor replacement, its distribution, sterilizing and re-assembling,

o in surgeries, where working mainly with patients with lowered immunity, we recommend a strict use of the disposable antibacterial filter

When used by HIV positive people, we recommend sterilizing the device with a 2% glutaraldehyde dilution [2].

7 . 2 . 2 C l e a n i n g

We recommend cleaning the device after every patient with cleaning agents approved by competent authorities of that particular country. You can use for example Sekusept, Bacilol etc. And for the cables of the accessories you can use e.g. Incidur spray etc.

7 . 2 . 3 D i s i n f e c t i o n

CAUTION! The patient's parts and spirometric sensor can be contaminated with bacteria and viruses of the patient. Therefore it is necessary to use cleaning agents and procedures intended and authorized for disinfecting. Pay attention to uncompromising use of only disinfected mouthpieces, spirometric sensors and seals. Applications suitable for disinfection are for example Chiroseptol, Gigasept Instru AF or Sekusept forte in dilution form. Disinfecting solutions:

1. Chiroseptol 2% with exposure time 30 min. 2. Gigasept Instru AF 2% with exposure time 30 min. 3. Gigasept Instru AF 3% with exposure time 15 min. 4. Sekusept forte 3% with exposure time 30 min.

Working process:

1. Removal of a part intended for cleaning and disinfection 2. Cleaning the part – under running water 3. Disinfection of the part – entire submersion of the part into a disinfectant solution with specified exposure

time. 4. Proper (multiple) rinse – under cold running drinking water 5. Air dry before utilization

The lifetime of the replaceable mouthpiece, spirometric sensor, seal and the nose clip is 1000 disinfection cycles. Notice: We recommend using uncompromisingly the disposable antibacterial filter in patients with TBC or HIV, but also with suspicion of these diseases. Warning: If you use disinfectants containing aldehydes, then the disinfected parts of the spirometry can change colour (become brown).


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We do not recommend using disinfectants containing peracetic acid or substances generating peracetic acid in disinfecting solution. However, if you use these disinfectants, the mechanical disengagement of the spirometric sensor can occur and damage the sensor.

7 . 2 . 4 S t e r i l i z a t i o n

We advise to carry out sterilization according to standard recommendations for plastic objects without hollow parts at maximal temperature of 121°C and sterilization time 20 minutes. After sterilization of the spirometric sensor it is necessary to let the sensor cool down for a temperature lower than 40°C before its next using. Otherwise the device will become mechanically damaged! The lifetime of the replaceable mouthpiece, spirometric sensor, seal and nose clip is 1000 sterilization cycles.

7 . 3 D E V I C E S A F E T Y

CAUTION!

The device is equipped with a protective system against the connection of different equipment other than supplied by the manufacturer; consequently it does not allow operation with equipment form other manufacturers. The BTL- 08 Spiro has applied parts of BF type. The device disuses any pharmaceuticals or matters, which would be applied or were an integral part of the device.

This connector relates only to the combined device BTL-08 ECG + Spiro. You will find its purpose in the relevant manual for BTL-08 ECG MT Plus and Lx.

This marked clamp is connected to the framework of the device. It relates only to the combined device BTL-08 ECG + Spiro. You will find its purpose in the relevant manual for BTL-08 EKG MT Plus and Lx. Safety precautions • Read carefully the service instructions before first activation of the device. • All personnel, using the device, must have a required service qualification in the health service; they must

especially know the contraindications of the examination with the device, all potential danger and effective procedures to prevent infection transmission.

• All personnel, using this device must be knowledgeable in the servicing technique, maintenance and verification of the device and about the principles of safe work with the device.

• Electrical mains connected to the device must be performed according to the existing valid standards (CSN 33 2140, IEC 364) and must be certificated according to these standards. If you are not sure, that the power mains supply is in perfect order, carry out a technical revision by an engineering inspector.

• Crosscheck, whether the parameters of the power mains supply correspond with the requirements of the device according to chapter Technical specifications and if the mains voltage switch placed on the rear panel apparatus is switched to the correct voltage according to the parameters of the power mains.

• The device is designed to work in an environment defined in chapter Technical specifications. It must not be used in an environment with threats of e.g. explosion hazard, or water penetration. The device must not be used in connection with flammable anaesthetics, or oxidative gases (O2, N2O etc.).

• Place the device out of direct sunlight and out of reach of strong electromagnetic fields, to avoid undesirable interactions. In case of undesirable interactions place the device away from source of disturbance, or contact the authorised BTL service centre.

• Before every use, examine the device properly (loose cables, damaged cable insulation, functions of the display, indicators, operating elements etc.) and in case of any discrepancy stop using the device and contact the authorised BTL service centre. If the behaviour of the device shows any divergences from the function procedure described in the instruction manual, stop using the device and contact the authorised BTL service centre.


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• If the device shows any signs of defects, or you are in doubt about its correct operation, stop working with the

device immediately. If you cannot detect the source of doubts even after careful reading through the instruction manual, appeal to the authorised service department of the BTL device without delay. If the device is used contrary to this instruction manual, or it is used in despite of the device showing functional divergences from this instruction manual, then the user is responsible for any damage caused by the device!

• Do not disassemble the device in any case. Dismantling and unlocking the safety cover can cause danger of electric shock. Eventual replacement of the lithium battery and lead-acid storage battery must by carried out by authorised BTL service centre.

• All materials and parts that come into direct contact with the patient's body (detergents used for cleaning the electrodes, mouthpieces...), must meet the appropriate standards, relevant to irritation, allergization, toxicity genotoxicity, carcinogenity according to the standards ISO 10993 - 1, ISO 10993 - 3, ISO 10993 5. The user himself is responsible for all these materials and parts that were not supplied by the BTL device distributor.

• Do not connect the connectors used for the accessories and the other connectors with anything other than the equipment intended by the service instructions, as it can cause danger of electric shock and serious damage of the device!

• The device does not radiate or does not use any toxic materials during its operation, storage and transport under the given conditions.

• When transferring the device from a cold environment into warm, wait before plugging into power mains, until the temperature levels (1 hour minimum).

• When switching the device off and on, there is a time delay necessary of at least 3 seconds. • The device does not cause any risk to the patients with cardiac pacemakers. • When disposing of the device after years of operation, it is necessary to remove the lithium battery and the lead-

acid storage battery. Dispose of them in a proper way – do not put the batteries into the communal waste. Then the device can be disposed of in the usual way. The device does not contain any toxic materials that could damage the environment when disposed of in the common way. Warning: removal of the batteries causes non reversible damage of the device. Execute only during ecological disposal of the device!

Procedure: - Unscrew the lower cover of the device - Use suitable tools to remove the batteries (position of the batteries see illustration)

BTL-08 Spiro

• It is not allowed to use the device and accessories other than according to the instruction manual. • Use recommended protective equipment when working with the device. • This device must be kept out of reach of the children. • Do not remove any covers from the device. Repairs must always be provided by the authorised BTL service

centre.

7 . 4 C O N D I T I O N S O F G U A R A N T E E

The manufacturer provides a 24 months guarantee for the device from the date of purchase. The lead-acid storage battery, expendable supplies and mobile parts of the device (pneumotachograph) guarantee is proved for 6 months (guarantee does not apply to common wear of the parts). Conditions of the guarantee determine, if the device is not used in compliance with this instruction manual, or unprofessional intervention to the device is carried out by third parties. In case of malfunction of the device always contact the BTL service centre.


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8 T E C H N I C A L S P E C I F I C A T I O N S

Type: BTL-08 Spiro BTL-08 Spiro Pro

Display: touch screen

dimensions (mm) 120 x 89

screen resolution 320 x 240 RGB (colour)

Keyboard: combined – functional + touch screen buttons

Discharged battery indication: acoustic + light

Printer:

paper width (mm) 112 / A4 through USB

paper type roll / A4 – office paper

printer resolution 200 dpi in Y-axis, 500 dpi in X-axis / 300 dpi

print type thermal, external through USB

Measurement parameters: BTPS correction automatic

inspire / expire yes / yes

forced profile

FVC, Best FVC, FEV1, Best FEV1, FEV6, PEF, FEV1/FVC, FEV6/FVC, FIVC, FIV1, PIF, MEF75, MEF50,

MEF25, Lung age

FVC, Best FVC, FEV0.75, FEV1, Best FEV1, FEV3, FEV6, PEF, FEV0.75/FVC,

FEV1/FVC, FEV3/FVC, FEV6/FVC, FEV0.75/SVC, FEV1/SVC, FEV3/SVC, FEV6/SVC, PIF, FIVC, FIV1, MEF75,

MEF50, MEF25, FEF75, FEF50, FEF25, MMEF, FET25, FET50, MIF75, MIF50,

MIF25, PEFT, FIF50, FEF50/FIF50, FEF50/SVC, FEV0.75/FEV6, FEV1/ FEV6,

FIV1/FIVC, VEXT, Lung age

relaxed profile - SVC, ERV, IRV, TV, IC, IVC

mvv profile - MVV, MVVf, MRf

PRE/POST bronchoprovocative test yes

Predictive values ECCS/ERS 1993, ECCS 1983, NHANES III, Knudson 1983, Knudson 1976, Roca 1986, CRAPO 1981, ITS, Perreira – Brazil, LAM, Gore – Australian,

Zapletal 1977

Stored records 50 250

User defined profiles - unlimited

Interpretation Enright, ATS, BTS

Child incentive yes

Device weight (max.) in kg: 3,2

Dimensions (in mm ): 330 x 270 x 74

Operating conditions: ambient temperature + 10 °C to + 40 °C

recommended ambient temperature + 17°C to +28°C (to avoid any provocative bronchial reaction)

relative humidity 25 % to 95 %

barometric pressure 700 hPa to 1100 hPa

position horizontal


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operation type permanent

Transport and storage conditions:

temperature - 10 °C to + 55 °C

relative humidity 25 % to 85 %

barometric pressure 650 hPa to 1100 hPa

position any

storage life 1 year

other conditions transportation only in supplied wrapping, recharge storage batteries minimally once a year

Technical specifications: flow range (litres/s) 16 l/with (inspire / expire)

accuracy (50 ml/s to 16 l/s) ± 5 % or 50 ml/s (greater value applies)

volume range (litres) 0,025 to 8 litres

accuracy (0,025 to 8l) ± 3 % or 50 ml (greater value applies)

flow resistance < 79 Pa / l/S

BTPS corrections: temperature sensor + 10°C to + 40°C

accuracy ± 3 % for 25°C

barometric pressure sensor 700 hPa to 1200 hPa

accuracy ± 2 % in mentioned range

relative humidity sensor 0 to 100 % RH

accuracy ± 4 % for 25°C, 30 to 80 % RH

Device power supply:

power input 40 VA

mains voltage ~ 99 V to 126 in (115 V rated voltage), AC ~ 198 V to 252 V (230 V rated voltage), AC

frequency 50 Hz to 60 Hz

Classification:

protection class II with functional grounding (according to IEC 536, CSN 33 0600 and IEC 60601 - 1)

T1A / 250V, tube safety fuse external fuse

5 x 20 mm, according to IEC 127 - 2

power switch on the back of the device, position 0 and I

IP code IP20

safety standards IEC 601 - 1, IEC 601 - 1 - 2, IEC 601 - 1 - 4, ISO 14971

spirometry standards EN 13826, ATS / ERS standards 2005

applied part type BF according to IEC 601 - 1

Internal chemical supplies:

battery lithium battery CR2032

lead-acid storage battery 1x 12 V / 1.2 Ah, 48x97x52 mm, maintenance - free

storage battery capacity 3 - 4 hours

charging time 10 hours (if completely discharged)

PC connection: USB


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8 . 1 L E G E N D O F T H E M E A S U R E M E N T P A R A M E T E R S

8 . 1 . 1 F o r c e d s p i r o m e t r y

FVC = Forced Vital Capacity [l] - maximal air volume the patient expires after maximal aspiration, however contrary to the vital capacity, the patient breathes out as fast as possible , PEF = Peak Expiratory Flow [l/s], maximum speed of peak flow achieved during forced expiration. It depends on the effort made with the cooperation of the patient, FEV0.75 = Time Forced Expiratory Volume [l], forced expiration of volume in defined time 0.75s from the start of the expiration, FEV1 = Time Forced Expiratory Volume [l], volume exhaled during the first second of forced expiration of vital capacity - „one-second vital capacity", FEV3 = Time Forced Expiratory Volume [l], volume exhaled during the first three seconds of forced expiration of vital capacity, FEV6 = Time Forced Expiratory Volume [l], volume exhaled in six seconds of forced expiration of vital capacity, FEV0.75/FVC = ratio [%] of forced expiratory volume 0.75 s from the start of expiration to maximum air volume exhaled as fast as possible by the patient after maximal aspiration, FEV1/FVC = ratio [%] of forced expiratory volume 1 second from the start of expiration to maximum air volume exhaled as fast as possible by the patient after maximal aspiration, FEV3/FVC = ratio [%] of forced expiratory volume 3 seconds from the start of expiration to maximum air volume exhaled as fast as possible by the patient after maximal aspiration, FEV6/FVC = ratio [%] of forced expiratory volume 6 seconds from the start of expiration to maximum air volume exhaled as fast as possible by the patient after maximal aspiration, PIF = Peak Inspiratory Flow [l/s] the biggest expiratory flow value gained during the whole measurement, FIVC = Forced Inspiratory Vital Capacity [l], after the total expiration, forced aspiration follows to the maximum position, FIV1 = Forced Inspiratory Volume [l], forced inspiratory volume in the first second, MEF75 = Maximum Expiratory Flow [l/s] - specified when the measurement finishes, it is a flow value during forced expiration defined from the curve, when 75 % of the air volume remains in the lungs, MEF50 = maximum Expiratory Flow [l/s], specified when the measurement finishes, it is a flow value during forced expiration defined from the curve, when 50 % of the air volume remains in the lungs, MEF25 = maximum Expiratory Flow [l/s], specified when the measurement finishes, it is a flow value during forced expiration defined from the curve, when 25 % of the air volume remains in the lungs, FEF75 = Forced Expiratory Flow [l/s] - specified after the end of measuring, it is a flow value during forced expiration defined from the curve, when 75 % of the air volume was exhaled from the lungs, FEF50 = Forced Expiratory Flow [l/s] - specified after the end of measuring, it is a flow value during forced expiration defined from the curve, when 50 % of the air volume was exhaled from the lungs, FEF25 = Forced Expiratory Flow [l/s] - specified after the end of measuring, it is a flow value during forced expiration defined from the curve, when 25 % of the air volume was exhaled from the lungs, MMEF = Maximal Mid- Expiratory Flow [l/s], specified by calculation after the end of measuring, sometimes also referred to as FEF25 - 75% as maximal mid expiratory flow in mid half of the exhaled FVC


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FET25 = Forced Expiratory Time [s], time necessary for expiration of 25% from the FVC value, measured from the start of measuring (Time Zero), it is specified by a reverse extrapolation, FET50 = Forced Expiratory Time [s], time necessary for expiration of 50% from the FVC value, measured from the start of measuring (Time Zero), it is specified by a reverse extrapolation, MIF75 = Maximum Inspiratory Flow [l/s], specified after the end of measuring, it presents flow values during forced aspiration, defined from the curve when 75% of the air volume is left to breathe in, MIF50 = Maximum Inspiratory Flow [l/s], specified after the end of measuring, it presents flow values during forced aspiration, defined from the curve when 50% of the air volume is left to breathe in, MIF25 = Maximum Inspiratory Flow [l/s], specified after the end of measuring, it presents flow values during forced aspiration, defined from the curve when 25% of the air volume is left to breathe in, PEFT = Peak Expiratory Flow Time [ms], time to PEF from 10 % to 90 % of the PEF flow value FIF50 = Mean Forced Inspiratory Flow [l/s], specified after the end of measuring, it is a flow value during forced aspiration, defined from the curve when 50 % of the air volume was breathed in to the lungs, FEF50/FIF50 = ratio [%] of a flow value during forced expiration defined from the curve when 50 % of the air volume was exhaled from the lungs, to a flow value during forced aspiration defined from the curve, when 50 % of the air volume was breathed in to the lungs, FEV0.75/FEV6 = ratio [%] of a forced expiration volume in the time of 0.75s from the start of expiration, to the volume exhaled within six seconds of the forced expiration of vital capacity, FEV1/FEV6 = ratio [%] of a forced expiration volume in the time of 1s from the start of expiration, to the volume exhaled within six seconds of the forced expiration of vital capacity, FIV1/FIVC = ratio [%] of forced aspiration volume in the first second, to the volume of forced aspiration of vital capacity, when forced aspiration to the maximal position follows the total expiration, EVE = Extrapolated Volume [l] is used as a criterion for an expiration start. It presents the exhaled volume in time from the start of expiration until the new time of expiration specified by reverse interpolation Lung age = [years], this parameter is intended mainly for the patients as a motivational figure to stop smoking


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8 . 1 . 2 R e l a x e d s p i r o m e t r y

SVC = Slow Vital Capacity [l], starts with deep expiration and finishes with maximum aspiration – but not forceful. Sometimes also referred to as EVC ERV = Expiratory Reserve Volume [l] - it is the difference in value of the maximum expiration volume and average value of the common breathing volume, IRV = Inspiratory Reserve Volume [l] - it is the difference in value of the maximum aspiration volume and average value of the common breathing volume, TV = Tidal Volume [l] - is the air volume inspired or exhaled during one aspiration or expiration, also referred to as Vt IC = Inspiratory Capacity [l], it presents the biggest possible air volume, that can be inspired after a previous relaxed expiration, IVC = Inspiratory Vital Capacity [l], is the maximal air volume, that can be slowly inspired after maximal expiration.

8 . 1 . 3 M e a s u r i n g o f t h e m a x i m u m p u l m o n a r y v e n t i l a t i o n v o l u m e

MVV = Maximal Voluntary Ventilation [l] -the total air volume, that flows at a maximal forced ventilation during 1 minute, measuring must last for at least 12 seconds, then the values will be completed in 1 minute, MVVf = Maximal Voluntary Ventilation frequency [Hz], the average respiratory frequency measured during MVV measuring, MRf = Maximum Respiratory frequency [s], maximum measured frequency of respiration during MVV measuring.


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8 . 2 P R E D I C T I V E V A L U E S

A summary of predictive values that are implemented in the BTL-08 Spiro and the BTL-08 Spiro Pro are described in the table, see below.


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8 . 3 R E L E V A N T S T A N D A R D S P E C I F I C A T I O N S A N D R E C O M M E N D A T I O N S

Name IEC, EN, ISO, MDD

Medical electric device. Part 1: General requirements for safety EN 60601 - 1

appendices to EN 60 601 - 1 A1, A2, A11 and A12

Medical electric device. Part 1 - 1: Systems IEC 60601 - 1 - 1

Medical electric device. Part 1: EMC - requirements and examinations IEC 60601 - 1 - 2

ISM – radio interference characteristics EN 55011

EMC – electrostatic discharge IEC 61000 - 4 - 2

EMC – radiated electromagnetic field IEC 61000 - 4 - 3

EMC – fast electric transient effects/pulse groups IEC 61000 - 4 - 4

EMC – shock pulse IEC 61000 - 4 - 5

Medical electric device. Part 4: Programmable electric medical systems IEC 60601 - 1 - 4

Medical device - risk analysis ISO 14791

Bio-compatibility of medical device ISO 10 993 - 1

Spirometers for measuring peak expiration EN 13826

Standardization in spirometry. ATS/ERS 2005

Statutory rules for determination of technical requirements to sanitary engineering assets NV 181/2001 Coll. MDD 93/42/EEC


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8 . 4 L I S T O F L I T E R A T U R E

[1] Spirometry in the Lung Health Study: Methods and Quality Control, A.R.R.D. 1991; 143:1215-1223 [2] Fišerová J., Chlumský J., Satinská J. a kol.: Funkční vyšetření plic.- Functional lung examination. GEUM, 2004. [3] Standardization of spirometry. ATS/ERS Task Force: Standardization of function testing. Eur respir J. 2005; 26: 319-338 [4] American Thoracic Society. 1994 Standardization of Spirometry. 1994 Update. Am. Rev. Respir. Dis. 152 : 1107-1136. [5] The European Standard EN 13826 : 2003 Peak Expiratory Flow Meters. Czech Edition ČSN EN 13826 : 2003. Český normalizační institut - Czech standards institute, 2003. [6] Prometheus. 1988. Matematické, fyzikální a chemické tabulky pro střední školy - Mathematical, physical and chemical tables for secondary schools. [7] Klepš, Z., Nožička J. a kol. 1986. Technické tabulky - Technical tables. SNTL ALFA, 1986. [8] Hankinson, J. L., Viola J. O. 1983. Dynamic BTPS correction factors for spirometric data. J. Appl. Physol. 44: 1354-1360. [9] Standardized Lung Function Testing by European Community for Coal and Steel 1983. [10] Hankinson John L., Odencrantz John R., Fedan Kathleen B. 1999. Spirometric Reference Values a Sample of the General U.S. Population. Am. J. Respir. And Critic. Care Medic. Vol. 159. [11] Quanjer Ph. H., Tammeling G. J., Cotes J. E., Pedersen O. F., Peslin R., Yernault J-C. 1993. Lung volumes and forced ventilatory flows. ERS Journals Ltd. 6, Suppl. 16, 5 – 40. [12] Morris J. F., M.D., Temple W. 1985. Spirometric "Lung Age" Estimation for Motivating Smoking Cessation [13] Knudson R. J., Slatin R. C., Lebowitz M. D., Burrows B. 1976. The Maximal Expiratory Flow-Volume Curve. Am. Rev. Respir. Dis. 113 : 587-600. [14] Knudson R. J., Lebowitz M. D., Holberg Catharine J., Burrows B. 1983. Changes in the Normal Maximal Expiratory Flow-Volume Curve with Growth and Aiging. Am. Rev. Respir. Dis. 127 : 725-734 [15] Ph. H. Quanjer, J. Stocks, G.Polgar, M. Wise, J. Karlberg, G. Borsboom; ERJ 1989, 2, Supp.4,184s-261s, Compilation of reference values for lung function measurements in children. [16] G. K. Arotock: Pulmonology Child Care, 1984. [17] Lam Kwok-Kwong, Pang Shing et al. A survey of ventilatory capacity in Chinese subjects in Hong Kong. Annals of Human Biology, 1982, vol. 9, No. 5, 459-472. [18] J. Roca, J. Sanchis, A. Agusti-Vidal, F. Segarra, D. Navajas, R. Rodriguez-Roisin, P. Casan, S. Sans. Spirometric reference values from a Mediterranean population. Bull. Eur. Physiopathol. Respir., 1986, 22, 459-472. [19] Gore C. J., Crockett A. J., Pederson D. G., Booth M. L., Bauman A., Owen N.: Spirometric standards for healthy adult lifetime non-smokers in Australia. Eur Respir J., 1995, 8: 773-782. [20] Carlos Alberto de Castro Pereira, Sueli da Penha Barreto, Joăo Geraldo Simőnes, Francisco W.L. Pereira, José Gerson Gerstler, Joge Nakatani. Valores de referęncia para a espirometria em uma amostra da populacao brasileira adulta, Jornal de Pneumologia 18(1):10-22, maco de 1992 [21] Crapo RO, Morris AH, Gardner RM. Reference spirometric values using techniques and equipment that meets ATS recommendations. Am Rev Respir Dis Volume 123, p.659-664, 1981. [22] Furguson GT, Enright PL, Buist AS, Higgins MW. Special Report: Office Spirometry for Lung Health Assessment in Adults - A Consensus Statement From the National Lung Health Education Program. Chest. Vol. 117(4) April, 2000 pages 1146-1161. [23] Lung Function Testing: selection of reference values and interpretative strategies, A.R.R.D., 144/ 1991:1202- 1218. [24] General considerations for lung function testing. ATS/ERS Task Force: Standardization of function testing. Eur Respir J., 2005; 26: 153-161. [25] A. Zapletal, T. Paul and M. Samanek, Significance of contemporary methods of lung function testing for the detection of airway obstruction in children and adolescents, Z Erkr Atmungsorgane, Aug 1977, 149(3): 343- 71 [26] Quanjer PhH, Borsboom GJJM, Brunekreef B, Zach M, Forche G, Cotes JE, Sanchis J, Paoletti P. Spirometric reference values for white European children and adolescents: Polgar revisited. Pediat Pulmonol 1995; 19: 135-142.


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8 . 5 M A N U F A C T U R E R

BTL Industries Ltd.

161 Cleveland Way

Stevenage

Hertfordshire

SG1 6BU

United Kingdom

8 . 6 S A L E A N D S E R V I C E

BTL zdravotnická technika, a.s.

Šantrochova 16

162 00 Praha 6

Czech Republic

Phone/fax: 235 363 606, 235 364 157, 235 361 392 e-mail: [email protected] http://www.btl.cz No part of this handbook may be duplicated, kept in storage and retrieval system or propagated in any way including electronic, mechanical, photographic or other records without previous agreement and written permission of BTL Industries Limited The BTL products are continuously innovated and developed. BTL Industries Limited reserves the right to innovate and improve the device without previous notice. Content of this document is supplied "as it is". There are no expressed or assumed guarantees provided in relation to accuracy, reliability or content of this document, except the legal requirements. BTL Industries Limited reserves the right to any time and without previous notice revise this document or terminate its validity.


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BTL CUSTOMER CARD Please, send it to the fax No +4202 353 63 606 or to the address: BTL zdravotnická technika, a.s.,

Šantrochova 16, 162 00 Praha 6.

About you: Company:............................................................................................................................ Name and surname:............................................................................................................ Address: ............................................................................................................................. ............................................................................................................................................ ............................................................................................................................................ Phone / fax: ........................................................................................................................ E-mail: ................................................................................................................................ Your BTL device: BTL type: .......................................................... Serial number: ........................................ Distributor's name: ............................................................................................................ What do you miss on the BTL device / what would you like to change: ............................ ........................................................................................................................................... ........................................................................................................................................... ........................................................................................................................................... ........................................................................................................................................... Are you satisfied with work of the distributor: YES NO If not, specify your reasons: .............................................................................................. ........................................................................................................................................... ...........................................................................................................................................

Manual Btl-08 Sd

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